Many COPD Patients On Medicare Struggle To Pay For Inhalers : Shots

Juanita Milton, who suffers from COPD, uses her nebulizer with albuterol sulfate at her home in Live Oak, Texas.

Carolyn Van Houten for Kaiser Health News

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Carolyn Van Houten for Kaiser Health News

Juanita Milton, who suffers from COPD, uses her nebulizer with albuterol sulfate at her home in Live Oak, Texas.

Carolyn Van Houten for Kaiser Health News

After a lifetime of smoking, Juanita Milton needs help breathing.

She’s tethered to an oxygen tank 24/7 and uses two drug inhalers a day, including Spiriva, which she calls “the really expensive one. “

“If I can’t afford it, I won’t take it,” Milton says.

The 67-year-old’s chest was heaving one recent morning from the effort of walking down the hallway into the kitchen. Her voice was constricted as she loaded medication into a device about the size of her palm.

“Capsule in. You close it and you push this blue button,” Milton says, demonstrating how the device punctures the pill. She then takes two labored breaths to inhale the powder inside the capsule. “And that’s it.”

Milton, like many Medicare enrollees, is on a fixed income. She has $2,000 a month to pay for a mortgage, car payment, Medicare premiums and other expenses.

“I got to stretch out that, plus I have the less costly medicines that I have to pay for and also my oxygen,” Milton says. “You can only stretch it so far.”

An estimated 1 in 9 Medicare beneficiaries are diagnosed with chronic obstructive pulmonary disease, or COPD. And, in 2014, COPD was the third-leading cause of death in the country, according to the U. S. Centers for Disease Control and Prevention. Inhalers like Spiriva and Advair account for billions in Medicare spending each year.

Yet, even if they are only responsible for monthly copays, many enrollees like Milton can’t afford their inhalers. Milton depends on free samples provided by her doctor for her prescription of one inhaler, Breo Ellipta, but the supply is limited, so she regularly skips one of the two daily doses. And, in order to afford her Spiriva, she applied for drugmaker Boehringer Ingelheim’s financial assistance program and received one year’s worth of free samples.

But, on a recent morning, Milton was down to two doses of Spiriva. Holding up a silver sleeve of medication, Milton says “This is all I have left. So, if [the drugmaker doesn’t] approve me for this year, I’m going to have to ask Dr. Stigall if there’s something else I can take.”

Dr. Brian Stigall of Hill Country Medical Associates in New Braunfels, Texas, keeps a closet full of free drug samples for patients like Milton.

Dr. Brian Stigall of Hill Country Medical Associates saves inhaler samples for his Medicare patients.

Sarah Jane Tribble/Kaiser Health News

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Sarah Jane Tribble/Kaiser Health News

Dr. Brian Stigall of Hill Country Medical Associates saves inhaler samples for his Medicare patients.

Sarah Jane Tribble/Kaiser Health News

“Thank goodness, the drug reps are good. They bring us lots of samples,” Stigall says. “I save those samples back for those Medicare patients.”

Without the inhalers, patients suffer, he says. “They are going to end up back in the hospital and they’re going to end up seeing me much more often.”

Patients who suffer a full-blown attack, due to low oxygen intake, could need three to seven days of emergency treatment, Stigall says.

Retiree Ken Wagar, who lives in Winter Haven, Fla., buys his inhalers overseas. Instead of paying Medicare copays of more than $500 for three-month supplies of Advair and Spiriva, Wagar pays $248 for the same amount of Advair and $73 for Spiriva.

“It’s common and easy,” says Wagar, 68. “You have to order in advance because it takes a while to ship. … You do what you have to do.”

Across the country, doctors who treat COPD say costs are a common problem for patients. Dr. David Mannino at the University of Kentucky College of Public Health says some patients cut pills in half or take a prescription once a day instead of twice, just to save money.

Dr. Momen Wahidi, a pulmonologist at Duke University School of Medicine, says many patients “weren’t able to use [an inhaler because they] couldn’t get it, couldn’t afford it. ” And, when Dr. Peter Castaldi of Brigham and Women’s Hospital in Boston surveyed thousands of Medicare patients in 2006, up to a third said they couldn’t take their medication because of cost.

“Even at a relatively, seemingly, low amount of $20 per month out-of-pocket costs, you could see the effects of cost on people being able to take their medications,” Castaldi says.

And prices have only increased since 2006. Spiriva’s list price has jumped 31 percent the past five years to $368 for a 30-day supply, according to drugmaker Boehringer Ingelheim. And Breo Ellipta’s price has risen 20 percent since 2013 to $321.74 a month, according to drugmaker GlaxoSmithKline.

Spokespeople for both drug companies say insured patients would not pay those prices because of discounts, rebates and other price concessions negotiated with insurers and pharmacy benefit managers. For example, GlaxoSmithKline estimated that the average out-of-pocket cost for patients with Medicare’s drug coverage, Medicare Part D, was $33 in 2015 when the drug’s list price was $281 for a month’s supply.

Inhaler samples provided by pharmaceutical representatives who visit the Hill Country Medical Associates in New Braunfels, Texas.

Sarah Jane Tribble/Kaiser Health News

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Sarah Jane Tribble/Kaiser Health News

Inhaler samples provided by pharmaceutical representatives who visit the Hill Country Medical Associates in New Braunfels, Texas.

Sarah Jane Tribble/Kaiser Health News

But it’s “not unusual [for patients] to be on more than one inhaler” and those costs add up, says Dr. Chien-Wen Tseng, with the University of Hawaii John A. Burns School of Medicine and the Pacific Health Research and Education Institute.

In a recent letter published in JAMA, Tseng analyzed Medicare’s prescription drug formularies in 2015 and the projected cost of deductibles and copays. She found that Medicare Part D beneficiaries with multiple inhalers could spend more than $2,800 in out-of-pocket costs annually.

The high price of inhalers is expensive for the Medicare program and “drives people into the doughnut hole,” she says. The dreaded doughnut hole is a coverage gap for Medicare Part D patients. Enrollees pay more for drugs out-of-pocket once the coverage gap is reached.

“Medicare Part D was really designed in 2006 with 2006 prices,” Tseng says. In 2017, with much higher drug prices, “does Medicare Part D really still work?”

For Milton, the answer seems obvious: It doesn’t. Most mornings after taking her Spiriva, Milton sits on her back patio. There, she talks with God.

“I don’t pray,” she says. “I talk. I carry on a conversation.”

And that conversation often turns to her struggles with COPD.

“I understand and I have to accept it. I know that it was my doing,” Milton says, adding, “everything is in his hands.”

Editor’s note: After this story was published, GlaxoSmithKline, which manufactures Breo Ellipta, noted that it recommends the drug be taken once a day. Doctors may prescribe twice-a-day dosage, however.

Sarah Jane Tribble is a senior correspondent at Kaiser Health News, an editorially independent newsroom that is part of the nonpartisan Henry J. Kaiser Family Foundation.

The Average Cost Of COPD Medications Over 1 Year

For patients that have been diagnosed with chronic obstructive pulmonary disease (COPD), medications are one method of treatment your doctor will most likely use to help reduce the severity of the symptoms of the disease. However, the average costs of COPD medications over one year may be quite high for many people.

The Average Cost of COPD Medications Over One Year Is Significant

The high average cost of COPD medications over one year is representative of the high overall yearly cost of the disease in the United States. For instance, in 2010, COPD costs for the country approached $50 billion with a per person average cost of $4,000 annually. In the same year, a COPD patient could expect to pay higher average annual medication costs depending on whether they were in stage one, two or three of the disease. The average annual medication costs per patient in 2010 were:

• $512 for patients in stage one
• $720 for patients in stage two
• $766 for patients in stage three

Eight years later, the average cost of COPD medication over one year has only continued to climb. The biggest reason for this continued cost climb is the continued increase in the cost of individual medications used to treat COPD. For example, three commonly prescribed medications for COPD symptoms are Advair, Combivent and Spiriva, and these three medications have average monthly costs of $286, $243 and $286 respectively. What this means is that patients with no insurance may end up paying more than $800 per month for just these three medications. The high average cost of COPD medications over one year would be almost insupportable for someone without insurance and can still be worrisome for patients who do have insurance.

The Lung Health Institute May Provide an Alternative to Costly Medications

At the Lung Health Institute, our team strives to help patients with lung diseases, such as COPD, find treatment strategies for their disease. One of the ways we may be able to assist you with your average cost of COPD medications over one year is cellular therapy. Cellular therapy uses your body’s own cells in ways that may lead to reductions in lung tissue inflammation and may promote natural healing to occur, and these benefits may reduce your need for COPD medications. For more information about dealing with the high average cost of COPD medications over one year, contact the Lung Health Institute now.

Special Features – 6 Popular COPD Medications (and What They Cost)

If you’ve turned on a television anytime in the past decade, you’ve undoubtedly seen ads for COPD medication — perhaps it’s one you’ve heard of or taken yourself in the past, or perhaps it’s a new one. If it seems like there are a lot of commercials that talk about COPD, it’s because there are a lot of commercials that discuss it.

While some are more popular than others, there are a handful that are the most often prescribed because doctors find that they work for the majority of their patients. While everyone is different and not everyone’s lungs respond to medication or dosage the way others do, most COPD patients end up on one (or more) of the following medications.

Here are the 6 most popular COPD medications and what you can expect to pay for them.

COPD, which stands for chronic obstructive pulmonary disease, is a chronic condition in which the “airways in your lungs become inflamed and thicken, and the tissue where oxygen is exchanged is destroyed. ” As more and more tissue is destroyed, less air is able to enter the lungs, resulting in a lower oxygen level in the body. Furthermore, it’s more difficult for the lungs to expel the carbon dioxide it’s able to make.

Sometimes referred to as chronic bronchitis or emphysema, COPD is quite common in the United States. According to the American Lung Association (ALA), more than 16.4 million Americans have COPD. That being said, the ALA believes there are many undiagnosed cases of COPD among Americans — probably for many reasons, including but not limited to poor access to healthcare or lack of awareness that symptoms people are experiencing warrant medical attention.

COPD is not a matter to be trifled with or ignored. ALA data shows that COPD is the “third leading cause of death by disease in the United States.” Because it’s a progressive disease with no cure, it will become a more serious health issue with age, but the negative effects of the disease can be managed in part so the patient can live more normally for as long as possible.

While COPD is preventable in many circumstances (by not smoking or spending a copious amount of time in poor air conditions), there is no cure once a person’s lungs have started showing symptoms. As with any other life-threatening disease, the earlier it’s discovered, the better. If doctors can help reduce inflammation in the tissue, it can prolong the patient’s life, in addition to their quality of life.

Inhaled corticosteroids are used to treat multiple lung conditions, including asthma and COPD. Steroids have been known to reduce inflammation in some cases, and when the inflammation is within the lungs, it’s best if the medication is inhaled so it can be directly applied to the affected area.

There are multiple medications that are used for this purpose, and which one works best for each person will vary. In many cases, the inhaler actually contains more than one medication to manage inflammation and bronchoconstriction.

Symbicort

Symbicort is used for both COPD and asthma control. It contains both budesonide (a corticosteroid) and formoterol fumarate dihydrate (a long-acting bronchodilator). The device looks much like a traditional fast-acting inhaler. Symbicort is designed to be taken via two actuations in the morning and two at night (120 doses per month). Obviously, this will vary according to the patient’s individual needs.

It’s been on the market for long enough at this point that it (finally) has a generic, which makes it more affordable, although not by nearly the same margin as it would cost to purchase from an online international pharmacy. In the United States, 120 actuations — or a one-month supply — of the lowest brand-name dose (80/4.5 mcg) costs about $370.00. The generic equivalent runs at about $250.00.

At NorthWestPharmacy.com, we sell 120 actuations of brand-name Symbicort for about $100.00. If you’d rather go with the generic, you’ll save even more money. The same quantity and dosage in the generic form only costs about $50.00.

Advair Diskus

Advair is a very popular dry powder inhaler that is used to treat patients with asthma and COPD. In this form, it’s in the shape of a disc, which is why the inhaled corticosteroid is called the Advair Diskus. (There is also a fast-acting inhaler that is separate from this medication.)

Like Symbicort, Advair has two active ingredients: fluticasone propionate (anti-inflammatory) and salmeterol xinafoate (bronchodilator). This medication is designed to be taken twice per day — one actuation in the morning, and another in the evening, making a one-month supply a total of 60 actuations.

In 2019, a generic form of Advair was finally approved, offering a more affordable alternative for people who have been paying hundreds of dollars per month for years — but even still, it’s expensive in the United States. The lowest dose of brand name Advair (100/50 mcg) costs about $380.00, whereas the generic costs about $125.00. It’s certainly less expensive, but a far cry from what people can find through online pharmacies.

At NorthWestPharmacy.com, we offer brand name Advair for about $70.00. Alternatively, the generic costs about $55.00.

Breo Ellipta

Breo Ellipta is similar in delivery method to the Advair Diskus, but the medication inside and the frequency is different. Breo is made up of fluticasone furoate and vilanterol. Fluticasone furoate actually suppresses your immune response so that the tissue doesn’t become inflamed, while vilanterol is a long-acting beta adrenergic agonist (LABA), which helps relax the bronchioles.

Breo was only approved in 2013, so at this point, there is no generic version available (and there probably won’t be for quite some time). As a result, it’s quite expensive. In the United States, a one-month supply of the lowest dose of Breo (100/25 mcg) costs about $420.00. Because of its high cost, it’s typically classified as a Tier 3 drug in the formulary, which means insurance companies don’t cover much of the cost, if any at all.

At NorthWestPharmacy. com, we offer the same dose and size of Breo Ellipta at a much lower price — about $190.00.

Spiriva

Spiriva is unique in that it comes in two different delivery methods. Regardless, the active ingredient is tiotropium, which is a long-acting muscarinic agent (LAMA) or anticholinergic. Both are inhaled, but one requires more force than the other — meaning, it needs a strong inhale, which can be difficult for COPD patients, especially as the condition progresses.

The Spiriva Handihaler (also known as “Spiriva with Device”) is a dry powder inhaler. Unlike Advair, it requires that a pill be placed into a special inhaler, which crushes the pill and the medication is inhaled in two puffs. This method requires a fair amount of force on the inhale in order to get the medication into the lungs.

Spiriva in the Handihaler is only available in one dosage (18 mcg) and there is no generic version currently available in the United States (original approval was in 2004). Therefore, a one-month supply costs about $516.00. However, there is a generic available at international pharmacies, such as NorthWestPharmacy.com. The generic version costs about $60.00. The brand name costs about $100.00.

The Spiriva Respimat delivers the same medication in a spray (also inhaled) that allows the medication to move in a slow-moving mist through the lungs. This delivery method does not require a harsh inhale and is better suited for people with weaker lung capacity.

The Respimat version of Spiriva is only available in one dosage (2.5 mcg) and there is no generic available at all, as the approval was granted in 2015. In the U.S. the cost is about the same as the Handihaler version ($516.00), but at NorthWestPharmacy.com, it costs about $120.00.

Trelegy Ellipta

Trelegy Ellipta uses the same device as the Breo Ellipta (Ellipta refers to the device — the first term is the brand name drug) but has one additional medication included. Trelegy incorporates fluticasone furoate, umeclidinium (another LAMA), and vilanterol trifenatate in their formula. It’s available in only one dosage (100/62.5/25 mcg).

Approved in 2017, Trelegy is the newest drug on this list and still without a generic. In the United States, Trelegy costs about $635.00. At NorthWestPharmacy.com, it costs about $130.00.

Fast-acting inhalers are sometimes necessary for people with COPD who are experiencing respiratory distress (wheezing, tightness), which could be caused by environmental factors, stress, or missing doses of medication. Long-term inhaled corticosteroids cannot substitute for fast-acting inhalers, and therefore, it’s often recommended that people with COPD keep a rescue inhaler on hand for emergencies.

Ventolin

Ventolin is the brand name of one of the most popular respiratory medications on the market. The active ingredient is albuterol, and it’s easily found in generic form. In the United States, brand name Ventolin (100 mcg, 200 actuations) costs about $68.00, but the generic is about $45.00.

While these prices are far lower than the others on this list, they’re still more affordable from international online pharmacies. At NorthWestPharmacy.com, the brand name version is about $25.00 and the generic costs about $20.00.

When it comes to inhalers, a large cause for the expense is the delivery method — or perhaps more accurately, the patents that are held on the mechanisms. Inhalers contain a few different moving parts (literally) that can affect the patent awarded to them.

Much like asthma inhalers, medications used to treat COPD use various propellant agents to deliver the medication into the patient’s lungs. Metered dose inhalers (MDIs) use chemical propellant agents (such as aerosol) to push into the lungs. This is how rescue (fast-acting) inhalers function, which makes sense because the medication needs to get there quickly with as little effort as possible on the part of the patient.

The other popular method of delivering medication is through a dry powder inhaler (DPI), which is similar to a MDI, but there is no chemical assisting in the inhalation. With a DPI (such as Advair Diskus and Breo Ellipta), a slide mechanism measures out the specific dose necessary and then the patient inhales sharply through the mouthpiece in order to suck the medication into their lungs.

The final method of delivery is through a nebulizer, which is very common among COPD patients who have progressed further in the disease and don’t have the lung strength they once did. Nebulizers are machines connected to masks that cover the nose and mouth. Medication is placed in the machine and then the patient wears the mask for a designated period of time, letting the drug get into the lungs without much effort.

The point of course, is that all of these mechanisms can be subject to patent protection, and if any of these devices are amended at any point, they can reapply for their patent protection, which often drives the cost of the medication up. Theoretically, the manufacturer can say that the new method is better and is worth more money.

Furthermore, pharmaceutical companies have been using the high cost of research and development to justify the high costs of their drugs for many years now. While there is some truth to this argument — it takes a lot of people a lot of hours over a lot of years in order to develop and release a new drug — the exact cost of research and development is rarely released, which leads some to believe that the price is overinflated.

Of course, none of this touches on the fact that the price of medication in the United States is essentially unchecked. While most countries have restrictions on how much pharmaceutical companies can charge citizens, the U.S. government has chosen to give manufacturers patents which protect their monopolies but then leave the pricing up to the monopoly itself when in most industries, government intervention to protect a monopoly, means the beneficiary of that protection yield something to benefit the public. Big Pharma in the United States really does get to have its cake and eat it too! Frankly, this doesn’t seem to be working out for Americans in need of medication, but that’s how things are for the time being.

As you can see from the medications on this list, it’s not difficult for Americans to find more affordable ways to access their medications. Online international pharmacies like NorthWestPharmacy.com are not only reliable but are extremely convenient — we can deliver your exact prescription directly to your door at a fraction of the price.

We don’t believe that anyone should have to choose between paying their bills and getting the medication they need. We also understand that it can be stressful to order your medication from an online pharmacy — especially if this is your first time.

Feel free to read through our frequently asked questions, which may give you answers you’re looking for, but if you don’t find what you’re looking for, don’t hesitate to contact us. For your convenience, we have a toll-free phone number: 1-866-539-5330. We’re happy to walk you through the ordering process or answer whatever questions you still have.

Differences, similarities, and which is better for you

Drug overview & main differences | Conditions treated | Efficacy | Insurance coverage and cost comparison | Side effects | Drug interactions | Warnings | FAQ

According to the American Lung Association, chronic obstructive pulmonary disease, or COPD, is the third leading cause of death by disease in the U.S. Over 16 million people have been diagnosed with COPD, with millions more likely affected but not yet aware. COPD is a chronic inflammatory lung disease. Patients with COPD often experience difficulty breathing, coughing, wheezing, and mucus production. COPD includes emphysema and chronic bronchitis. Two common medications used to manage COPD are orally inhaled medications called Incruse Ellipta and Spiriva.

Incruse Ellipta and Spiriva are both brand-name medications indicated for the long-term maintenance treatment of COPD. Both drugs are approved by the U.S. Food and Drug Administration (FDA). They are classified in a group of medications called anticholinergics. They work by relaxing the muscles in the lungs, making breathing easier.

Although Incruse Ellipta and Spiriva are both anticholinergics used for COPD, they are not exactly the same. Continue reading below to learn more about each medication.

What are the main differences between Incruse Ellipta and Spiriva?

Incruse Ellipta and Spiriva are both anticholinergic medications, available in brand name only. They are also known as long-acting muscarinic antagonists (LAMA).

The chemical name of Incruse Ellipta is umeclidinium. It is available in inhaler form only. GlaxoSmithKline (GSK) makes Incruse Ellipta.

The chemical name of Spiriva is tiotropium bromide. It is available as both an oral capsule (for oral inhalation, not to be swallowed—also called a dry powder inhaler) and an oral inhalation mist. Boehringer Ingelheim Pharmaceuticals makes Spiriva.

Conditions treated by Incruse Ellipta and Spiriva

Incruse Ellipta and Spiriva are indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD). More specifically, the Spiriva Handihaler manufacturer information notes that it is used to reduce exacerbations in COPD patients.

Spiriva Respimat has one additional indication—maintenance treatment of asthma in patients ages 6 years and older.

Neither drug is to be used for an acute attack.

Is Incruse Ellipta or Spiriva more effective?

There is minimal data comparing the two drugs directly. A 12-week study compared the efficacy and safety of Incruse Ellipta and Spiriva in just over 1,000 patients with COPD. The primary endpoint was trough forced expiratory volume in one second (also called FEV1) at day 85. Patients were evaluated using St George’s Respiratory Questionnaire and other assessments. Both drugs showed meaningful improvements in quality of life and were well-tolerated in terms of safety. The study concluded Incruse Ellipta to be more effective than Spiriva.

Only your healthcare provider can determine the most effective medication for you. He or she can consider the severity of your symptoms and your medical history, along with other medicines you take that could potentially interact with Incruse Ellipta or Spiriva.

Coverage and cost comparison of Incruse Ellipta vs. Spiriva

Insurance plans and Medicare Part D cover both Incruse Ellipta and Spiriva, but the coverage amount varies by plan.

The out-of-pocket price of an Incruse Ellipta inhaler is about $477, but you can use a SingleCare card to lower the price to about $306.

The out-of-pocket price of a Spiriva Handihaler is about $634, and a Spiriva Respimat is about $600. Using a SingleCare coupon will lower the price to approximately $404 for either the Handihaler or the Respimat.

Common side effects of Incruse Ellipta vs. Spiriva

The most common side effects of Incruse Ellipta are nasopharyngitis (common cold), upper respiratory tract infection, and cough.

Spiriva’s most common side effects are upper respiratory infection, sinusitis, chest pain, dry mouth, constipation, and urinary tract infection.

This is not a complete list of side effects. Other adverse effects may occur. Contact your healthcare provider for a full list of side effects of Incruse Ellipta and Spiriva.

Source: DailyMed (Incruse Ellipta), DailyMed (Spiriva)

Drug interactions of Incruse Ellipta vs. Spiriva

Because Incruse Ellipta and Spiriva are anticholinergic medications, they should not be used with other anticholinergic medications. The combination could cause an increase in side effects, like urinary retention or narrow-angle glaucoma.

Other drug interactions may occur. Consult your healthcare provider for a full list of drug interactions.

Warnings of Incruse Ellipta and Spiriva

• Do not use Incruse Ellipta or Spiriva if you have a severe hypersensitivity to milk proteins or any of the ingredients.
• Incruse Ellipta or Spiriva are not intended for use in rapidly deteriorating or potentially life-threatening COPD acute episodes. These drugs have not been studied in acute episodes and should not be used to relieve acute symptoms. Do not take extra doses for relief of acute symptoms. Your healthcare provider should give you instructions on managing an acute episode—you will likely use a different, short-acting inhaler as a rescue inhaler.
• Incruse Ellipta or Spiriva may cause a potentially life-threatening paradoxical bronchospasm (worsening of breathing or wheezing), which should immediately be treated with a short-acting bronchodilator inhaler. If this occurs, discontinue Incruse Ellipta or Spiriva immediately. Your healthcare provider may prescribe an alternative treatment.
• Incruse Ellipta or Spiriva may cause hypersensitivity reactions, including anaphylaxis, angioedema, itching, or rash. Discontinue Incruse Ellipta or Spiriva and contact your healthcare provider if any of these reactions occur. If you have trouble breathing or experience swelling around your lips, tongue, and mouth, seek emergency medical treatment.
• Use Incruse Ellipta or Spiriva with caution in patients with narrow-angle glaucoma. Patients and their prescribers should look for symptoms of acute narrow-angle glaucoma (eye pain, blurry vision, visual halos). Consult your healthcare provider immediately if any of these symptoms occur.
• Use Incruse Ellipta or Spiriva with caution in patients with urinary retention. Patients and prescribers should be aware of urinary retention symptoms, such as painful urination and difficulty urinating. Consult your healthcare provider immediately if you experience these symptoms.

Spiriva only:

• Monitor patients with moderate to severe renal impairment for anticholinergic effects.
• Capsules are for oral inhalation only and should not be swallowed. Use capsules only with the Handihaler device.

Frequently asked questions about Incruse Ellipta vs. Spiriva

What is Incruse Ellipta?

Incruse Ellipta is an anticholinergic medication used for COPD. It helps to relax the lungs, making breathing easier.

What is Spiriva?

Spiriva is also an anticholinergic medication used for COPD. It is available as an inhaled capsule and also as an inhalation mist.

Are Incruse Ellipta and Spiriva the same?

Both medications are similar and in the same category of drugs. However, they do have some differences, such as side effects and dosage, outlined above.

Is Incruse Ellipta or Spiriva better?

Limited data is available comparing Incruse Ellipta to Spiriva. One study showed Incruse Ellipta to be more effective, but both medications to be equally safe. Your healthcare provider can determine which drug is better for you.

Can I use Incruse Ellipta or Spiriva while pregnant?

There is not enough information on the effects of Incruse Ellipta or Spiriva in pregnancy. Consult your OB-GYN for medical advice. If you are already taking Incruse Ellipta or Spiriva and find out that you are pregnant, consult your OB-GYN.

Can I use Incruse Ellipta or Spiriva with alcohol?

Although Incruse Ellipta or Spiriva does not interact with alcohol, drinking alcohol over a long time can increase COPD symptoms and weaken your immune system, worsening your COPD symptoms. Consult your healthcare provider for more information about alcohol and COPD.

Is Incruse Ellipta a steroid?

No. Incruse Ellipta is not a steroid. It is classified as an anticholinergic medication. It relaxes the muscles in the airways to make breathing easier.

Some inhalers do contain an inhaled corticosteroid and are used to treat COPD. Advair contains fluticasone (a steroid) and salmeterol (a long-acting beta-agonist). Another example is Breo Ellipta, which contains fluticasone furoate (a steroid) and vilanterol (a long-acting beta-agonist).

What inhaler is equivalent to Spiriva?

Other inhalers in the same category of Spiriva and Incruse Ellipta include Tudorza Pressair (aclidinium) and Seebri Neohaler (glycopyrrolate).

What’s the best inhaler for COPD?

That’s a tough question. It depends on a few factors, such as severity and type of symptoms, your medical history, and other medicines you take. Your healthcare provider can determine which inhaler is best for you.

There are dozens of inhaled medications on the market. Here are a few commonly prescribed inhaled treatments for COPD:

SABA (short-acting bronchodilators, or short-acting beta-agonists): Albuterol HFA, Proair HFA, Proventil HFA, Ventolin HFA, Xopenex

LABAs (long-acting beta2 agonists): Brovana (arformoterol), Serevent (salmeterol)

LAMAs (long-acting muscarinic antagonists): Incruse Ellipta (umeclidinium), Seebri (glycopyrrolate), Spiriva (tiotropium) Respimat or Handihaler, Tudorza Pressair (aclidinium)

LAMA + LABA combination inhaler: Anoro Ellipta (umeclidinium/vilanterol), Bevespi Aerosphere (glycopyrrolate/formoterol), Stiolto Respimat (olodaterol/tiotropium),

Utibron Neohaler (indacaterol/glycopyrrolate)

Inhaled corticosteroids: Qvar RediHaler (beclomethasone), Pulmicort Flexhaler (budesonide)

Combination corticosteroid + LABA: Symbicort (budesonide/formoterol), Advair (fluticasone/salmeterol), Breo (fluticasone/vilanterol), Dulera (mometasone/formoterol)

TRELEGY for COPD | TRELEGY ELLIPTA (fluticasone furoate, umeclidinium, and vilanterol)

View transcript

ANNOUNCER:
Once-daily TRELEGY is a prescription medicine used long term to treat chronic obstructive pulmonary disease, including chronic bronchitis, emphysema, or both, for better breathing and fewer flare-ups. TRELEGY is not used to relieve sudden breathing problems and won’t replace a rescue inhaler. Remember to watch the complete video to see additional safety information.

TEXT ONSCREEN:
Once-daily TRELEGY 100/62.5/25 mcg is a prescription medicine used long term to treat chronic obstructive pulmonary disease (COPD), including chronic bronchitis, emphysema, or both, for better breathing and fewer flare-ups. TRELEGY is not used to relieve sudden breathing problems and won’t replace a rescue inhaler. Watch the complete video to see additional safety information.

Important Safety Information

• Do not use TRELEGY to relieve sudden breathing problems. Always have a rescue inhaler with you to treat sudden symptoms.
• Do not use TRELEGY if you have a severe allergy to milk proteins or are allergic to any of the ingredients in TRELEGY. Ask your healthcare provider if you are not sure.
• Do not use TRELEGY more often than prescribed.
• Do not take TRELEGY with other medicines that contain a long-acting beta2-adrenergic agonist (LABA) or an anticholinergic for any reason. Tell your healthcare provider about all your medical conditions and about all the medicines you take.

Please see additional Important Safety Information on this web page.
Please see full Prescribing Information, including Patient Information, on this web page.

TEXT ONSCREEN: How TRELEGY works

DR. CORBRIDGE:
TRELEGY really is a first of its kind…

TEXT ONSCREEN:
Dr. Corbridge, Pulmonologist

DR. CORBRIDGE:
…that provides three of the important medications that we currently know work in patients with COPD.

TEXT ONSCREEN:
Dr. Corbridge is a physician and was a GSK employee at time of filming.

DR. CORBRIDGE:
So it has two bronchodilators.

TEXT ONSCREEN:
TRELEGY won’t replace a rescue inhaler.

DR. CORBRIDGE:
They’re called LAMAs and LABAs. These will open up the airway to improve symptoms, and the main one there being shortness of breath. And it has that anti-inflammatory medication…

TEXT ONSCREEN:
LABA opens your airways. LAMA keeps them open. ICS reduces inflammation.

DR. CORBRIDGE: …that really is positioned to cut down on risk for exacerbations, and it’s conveniently administered. One puff, once a day.

TEXT ONSCREEN:
TRELEGY won’t replace a rescue inhaler.

TEXT ONSCREEN: Finding out about TRELEGY

MIKE:
Well, I went to the doctor and I actually felt like I was losing ground. And I had been reading a magazine, and there was another medicine to go along with what I was taking.

TEXT ONSCREEN:
Real patients who were taking TRELEGY at the time of filming and one of their caregivers. GSK paid them for their time and expenses for sharing their unique experiences. Individual results may vary.

MIKE:
And I asked her, I said, “Would this help me?” And she said, “You know we can try that,” and she actually walked out of the room and came back in. She said, “You know what, wait a minute, let’s try you on TRELEGY.”

TEXT ONSCREEN:
Mike

MELISSA:
I had seen it on television about this drug TRELEGY. When I got to my doctor, I noticed there’s a poster up on his wall with the inhaler…

TEXT ONSCREEN:
Melissa

MELISSA:
…and I said “Now how about this stuff?” And at the same time, he said to me, “I think I want you to try this,” and we’re both pointing at it. And, I’m so glad he did because I feel better.

TEXT ONSCREEN:
Individual results may vary.

TEXT ONSCREEN: Noticing the results

DIANE:
With the right medication, you can still get out there.

TEXT ONSCREEN:
Diane
Individual results may vary.

DIANE:
I do spend time with my grandkids now. If they want to go to the park, if they want to go somewhere, I can take them.

TEXT ONSCREEN:
Individual results may vary.

RODNEY:
We’ve got plans now more so than ever of traveling a little bit.

TEXT ONSCREEN:
Rodney
Individual results may vary.

MELISSA: Now that I’m on TRELEGY, I’ve noticed a difference in my breathing. Overall, I noticed that I’m feeling like I can go a little bit longer. And for me that’s a good thing. I can maybe dance a little bit longer. That would be great, too.

TEXT ONSCREEN:
Individual results may vary.

TEXT ONSCREEN: Want more from a COPD treatment? Ask your doctor if TRELEGY is right for you

ANNOUNCER:
TRELEGY won’t replace a rescue inhaler for sudden breathing problems.

TEXT ONSCREEN:
TRELEGY won’t replace a rescue inhaler.

ANNOUNCER:
Tell your doctor if you have a heart condition or high blood pressure before taking it.

ANNOUNCER:
Do not take TRELEGY more than prescribed. TRELEGY may increase your risk of thrush, pneumonia, and osteoporosis.

TEXT ONSCREEN:
Use TRELEGY only once a day, every day.

ANNOUNCER:
Call your doctor if worsened breathing, chest pain, mouth or tongue swelling, problems urinating, vision changes, or eye pain occur. 

TEXT ONSCREEN:
Click here to watch a video on why TRELEGY might be right for you

Please see additional Important Safety Information and full Prescribing Information, including Patient Information on this web page.

TRELEGY ELLIPTA was developed in collaboration with INNOVIVA. The shape of the ELLIPTA inhaler is a trademark of GSK. Trademarks owned or licensed by GSK. ©2020 GSK or licensor. FVUVID200022 September 2020. Produced in USA.

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Cost-effectiveness of a single inhaler triple therapy versus ICS/LABA in COPD

Abstract

Background: IMPACT (InforMing the PAthway of COPD Treatment, NCT02164513), showed superior exacerbation reduction and lung function improvement with single inhaler, once-daily fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) 100/62.5/22μg vs once-daily FF/VI 100/22μg, for patients with moderate/severe COPD.

Objectives: The cost-effectiveness of FF/UMEC/VI vs FF/VI was assessed, from a Canadian public payer perspective.

Methods: A validated linked risk equation model (Briggs, Med Decis Making 37;4 2017), which predicts COPD disease progression, associated healthcare costs and health outcomes, was populated with baseline characteristics, efficacy and medication use from IMPACT. Canadian healthcare resource unit costs and drug costs were applied, with future costs and health outcomes discounted at 1.5% annually. Analysis was probabilistic, with a lifetime horizon and outputs including exacerbation rates, costs (2017 CAD), quality-adjusted life years (QALYs) gained and incremental cost effectiveness ratio (ICER) per QALY.

Results: Compared with FF/VI, FF/UMEC/VI treatment resulted in fewer moderate and severe exacerbations (10.52 and 3.38 vs 11.13 and 3.48), mean (95% CI) incremental costs and QALYs of $2,598 ($2,010, $3,268) and 0.13 (0.09, 0.18), and an ICER of $19,649 per QALY ($15,406, $26,454). The probability of FF/UMEC/VI being cost-effective vs FF/VI was 100% at a willingness-to-pay threshold of $50,000 per QALY. Results were most sensitive to time horizon, and efficacy of treatment post-discontinuation.

Conclusions: FF/UMEC/VI was predicted to improve health outcomes and to be a cost-effective option for treatment of moderate/severe COPD compared with FF/VI, in Canada.

Footnotes

Cite this article as: European Respiratory Journal 2018 52: Suppl. 62, PA3154.

This is an ERS International Congress abstract. No full-text version is available. Further material to accompany this abstract may be available at www.ers-education.org (ERS member access only).

• Copyright ©the authors 2018

A Review of the 2019 GOLD Guidelines for COPD

US Pharm. 2019;44(7):HS-8-HS-16.

ABSTRACT: Inhalers used in the treatment of chronic obstructive pulmonary disorder (COPD) come in a variety of novel mono-, dual-, and triple-therapies. These inhalers may contain short-acting beta₂ agonists, long-acting beta₂ agonists, short-acting muscarinic antagonists, long-acting muscarinic antagonists, or inhaled corticosteroids. In recent years, novel inhalers have entered the market in a variety of delivery devices, active ingredients, and costs. The Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines classify a patient’s COPD group and provide first-line therapy options. Improper inhaler technique and cost may pose a barrier to medication adherence. Inhaler selection should be individualized based on patients’ GOLD COPD classification, preference, ease of inhaler use, and cost.

Chronic obstructive pulmonary disorder (COPD) develops over time as the small airways become inflamed due to the inhalation of cigarette smoke or other noxious particles. The chronic inflammatory response may induce parenchymal tissue destruction resulting in emphysema, the disruption of normal repair and defense mechanisms resulting in small airway fibrosis. Generally, the inflammatory and structural changes of the small airways increase with disease severity.

Patients with COPD typically present with progressive shortness of breath, a chronic cough or recurrent wheeze, and chronic sputum production. Patients’ airflow limitation with a post-bronchodilator forced expiratory volume/forced vital capacity (FEV₁/FVC) <0.7 is further classified based on the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines as either GOLD 1 (mild), GOLD 2 (moderate), GOLD 3 (severe), or GOLD 4 (very severe). Patients’ symptom burden and risk of exacerbation are classified into GOLD groups A through D; this is used to guide patients’ therapy. Classification of airflow limitation (grades 1-4) and symptom burden with exacerbation risk (groups A-D) is patient-specific and can occur in a variety of combinations.

Pharmacologic therapy for COPD is used to decrease symptoms, reduce the frequency and severity of exacerbations, and improve exercise intolerance. Common classes of medications used in treatment of COPD include beta₂ agonists, antimuscarinics, inhaled corticosteroids (ICS), and combination therapy. Identification and reduction of exposure to risk factors, such as cigarette smoke, air pollutants, and occupational fumes, are also important in treatment and prevention of COPD. This review will summarize the updated 2019 GOLD recommendations on managing COPD, along with evidence and cost information on various inhalers.¹

Diagnosis, Management, and Prevention of COPD

According to the GOLD 2019 Global Strategy for the Diagnosis, Management, and Prevention of COPD guideline update, first-line pharmacologic therapy depends on the patient’s GOLD classification (FIGURE 1.) Short-acting bronchodilators (short-acting muscarinic antagonist [SAMA] or short-acting inhaled beta₂ agonist [SABA]) should be prescribed to all patients for immediate symptom relief, regardless of their GOLD classification.¹

For Group A patients, a short- or long-acting bronchodilator (long-acting muscarinic antagonist [LAMA] or long-acting beta₂ agonist [LABA]) is recommended based on their effects on patients’ breathlessness.

For patients classified in Group C, initial therapy should consist of a long-acting bronchodilator; LAMAs are superior to LABAs regarding COPD exacerbation.

For Group B patients, the guidelines do not recommend one class of long-acting bronchodilator over another for initial symptoms; initial therapy with two long-acting bronchodilators may be considered in patients who are experiencing severe breathlessness on monotherapy.

In Group D, a LAMA/LABA combination can be chosen as initial treatment in patients experiencing more severe symptoms, such as greater dyspnea and/or exercise intolerance. The 2019 guideline update recommends a LABA/ICS combination for initial treatment in patients with an eosinophil count greater than 300 cells/µL or those with a history of asthma and COPD. Patients who develop exacerbations while on a LAMA/LABA may be escalated to a LABA/LAMA/ICS, including the once-daily inhaler fluticasone furoate/umeclidinium/vilanterol (Trelegy Ellipta).

Preventive measures recommended by the 2019 GOLD guidelines include vaccinations and smoking cessation. The yearly influenza vaccine and the PPSV23 and PCV13 pneumococcal vaccines are recommended in all patients with COPD.² PPSV23 is recommended for patients aged 19 to 64 years, and PCV13 is recommended for patients aged 65 years and older, administered at least 1 year after PPSV23. Smoking cessation has the greatest ability to influence COPD disease progression.³ The guidelines recommend brief interventions, such as asking about tobacco use; advising the user to quit; assessing willingness to quit; assisting in quitting; and arranging follow-up contact with the patient. OTC quit aids include nicotine gum, lozenges, and patches.

Clinical Trials in COPD Management

The SUMMIT study by Calverley and colleagues compared fluticasone furoate monotherapy (Arnuity Ellipta), fluticasone furoate with vilanterol (Breo Ellipta) and vilanterol monotherapy and their rates of FEV₁ decline.⁴ The purpose of the study was to assess whether drug treatment could modify loss of lung function in patients with GOLD grade 2, or moderate COPD. Spirometry was measured every 12 weeks as part of a randomized, placebo-controlled trial of 16,485 patients with GOLD grade 2 COPD. Results indicated a decline in FEV₁ of 38 mL/y in those using fluticasone furoate in combination with vilanterol or as monotherapy as compared with placebo (-46 mL/y, P <.03) and vilanterol monotherapy (-47 mL/y, P <.005). FEV₁ decline was found to be greater in current smokers, those with lower BMI, males, and patients with established cardiovascular disease. In patients with moderate COPD and heightened cardiovascular risk, fluticasone furoate alone or in combination with vilanterol significantly reduced the rate of FEV₁ decline.

The SPARK study by Wedzicha and and colleagues evaluated the effect of dual, long-acting bronchodilator therapy on exacerbations in patients with GOLD grades 3-4, or severe and very severe COPD, with one or more exacerbations in the past year.⁵ In this parallel group study, 2,224 patients were randomly assigned to once-daily QVA149 (fixed-dose combination of indacaterol/glycopyrronium 110/50), glycopyrronium 50 µg, or tiotropium 18 µg. Patients receiving once-daily treatment with QVA149 or glycopyrronium were both double-blinded, while the once-daily tiotropium treatment group was open-label. QVA149 resulted in a statistically significant decrease in mild (15%, P = .0072) and moderate-to-severe (12%, P = .038) exacerbations compared with the glycopyrronium treatment group. Compared to tiotropium, there was a statistically significant decrease in mild (16%, P = .0052) exacerbations in the QVA149 treatment group. There were no statistically significant differences between treatment groups with regard to adverse medication events such as bacterial upper-respiratory tract infection, nasopharyngitis, and viral upper-respiratory tract infection. Overall, the dual bronchodilator QVA149 was superior in preventing moderate-to-severe COPD exacerbations as compared with glycopyrronium and tiotropium. These results indicate a potential benefit in dual bronchodilation as a treatment option for patients with severe and very severe COPD.

The IMPACT trial by Lipson and colleagues aimed to assess the efficacy of a novel triple-therapy inhaler, fluticasone furoate/umeclidinium/vilanterol (Trelegy Ellipta), versus traditional fluticasone furoate/vilanterol (Breo Ellipta) or umeclidinium/vilanterol (Anoro Ellipta) therapy.⁶ In the double-blind, parallel-group, randomized controlled trial, 10,355 patients were studied in 37 countries from June 2014 to July 2017. The IMPACT trial aimed to assess the rate of COPD exacerbations in patients with GOLD grades 2-4 COPD during treatment with each therapy over 52-week periods. A moderate exacerbation was defined as one that required treatment with oral/systemic corticosteroids and/or antibiotics that did not result in hospitalization, whereas a severe exacerbation would result in hospitalization or death. Results demonstrated an incidence of moderate or severe exacerbations as 1.07 and 1.21 per year in the fluticasone furoate/vilanterol and umeclidinium/vilanterol groups, respectively, as compared with 0.92 per year in the fluticasone furoate/umeclidinium/vilanterol group (P <.001). In the average COPD population, yearly exacerbations are between two and three.⁷ Common adverse events (1%-10% incidence) reported for the fluticasone furoate/umeclidinium/vilanterol group were pneumonia, lower-respiratory tract infection, cardiac arrhythmia, and anticholinergic effects such as dry mouth or confusion. The authors concluded that use of fluticasone furoate/umeclidinium/vilanterol resulted in a lower rate of moderate or severe COPD exacerbations versus the traditional fluticasone furoate/vilanterol and umeclidinium/vilanterol therapy. Fluticasone furoate/umeclidinium/vilanterol was also shown to reduce the rate of hospitalizations when compared to umeclidinium/vilanterol therapy.⁶

Adverse Effects of COPD Inhalers

Beta₂ agonists (SABAs, LABAs) can produce sinus tachycardia and precipitate cardiac-rhythm disturbances in susceptible patients. Hypokalemia can occur, especially when beta₂ agonists are combined with thiazide diuretics, as can increased oxygen consumption in patients with heart failure, but these effects decrease over time.^8,9

Inhaled antimuscarinics (SAMAs, LAMAs) are poorly absorbed, which limits systemic side effects. The main side effect of inhaled antimuscarinics includes dry mouth. Some patients using ipratropium reported a bitter, metallic taste following use. There have also been reports of a small increase in cardiovascular events in COPD patients treated with ipratropium.¹⁰ However, in a large, long-term clinical trial in COPD patients, tiotropium added to standard therapies had no effect on cardiovascular risk.¹¹

Inhaled corticosteroids such as fluticasone and mometasone are also associated with superficial adverse drug events such as oral candidiasis (thrush), hoarse voice, skin bruising, and pneumonia.¹² To mitigate these risks, patients should “swish and spit” after administration.

Common adverse events of the novel triple combination inhaler fluticasone furoate/umeclidinium/vilanterol include cough, headache, backache, diarrhea, and altered sense of taste.¹³ It is important to note that fluticasone furoate/umeclidinium/vilanterol has a higher incidence of pneumonia compared with LAMA/LABA combinations such as umeclidinium/vilanterol. There are no significant differences for the risk of pneumonia between fluticasone furoate/umeclidinium/vilanterol and LABA/ICS inhalers.⁶

Proper Inhaler Techniques

Reviewing inhaler technique is recommended at initiation and follow-up. The novel inhalers on the market come in a variety of delivery devices such as Ellipta, Pressair, Respimat, and Neohaler.

Ellipta: Umeclidinium (Incruse Ellipta) and umeclidinium/vilanterol (Anoro Ellipta) are formulated as Ellipta devices containing an inhalation powder. To use an Ellipta inhaler: Slide the cover down until a click is heard, breathe out gently (away from inhaler), put the mouthpiece in the mouth and close the lips, to form a good seal (but do not cover vents), breathe in steadily and deeply, hold the breath for 5 seconds, breathe out gently, and slide the cover upward as far as it will go to cover the mouthpiece.¹⁴

Pressair: Aclidinium bromide (Tudorza Pressair) is formulated as a Pressair device containing an inhalation powder. To use a Pressair inhaler: Remove the protective cap by gently squeezing the arrows on the side of each cap, hold the inhaler with the mouthpiece facing you with the green button facing up, press the green button down and release before placing mouthpiece in mouth, assure the control window has changed from red to green, breathe out gently (away from inhaler), put the mouthpiece between the lips, and breathe in quickly and deeply.¹⁵

Respimat: Olodaterol (Striverdi Respimat) is formulated as a Respimat device containing an inhalation spray. To use a Respimat: After initial priming, hold inhaler upright and turn base in direction of arrows on the label until it clicks (half of a turn), open cap until it snaps fully open, breathe out (away from inhaler), put mouthpiece between the teeth and close the lips to form a good seal (but do not cover vents), breathe in slowly and deeply through the mouth while pressing down on the dose button, hold the breath for 5 seconds and remove the inhaler from the mouth, breathe out gently, and replace the cap.¹⁶

Neohaler: Glycopyrronium/indacaterol (Utibron Neohaler) is formulated as a Neohaler dry-powder device. To use a Neohaler inhaler: Remove the cap, tilt the mouthpiece to open the inhaler, remove one capsule from the blister card, place the capsule into the capsule chamber, close the mouthpiece fully, hold the inhaler with the mouthpiece facing up and press both piercing buttons at the same time, release buttons, breathe out gently (away from inhaler), place the mouthpiece in the mouth, breathe in steadily and deeply, hold the breath for 5 seconds, breathe out gently, and remove the capsule from the capsule chamber.¹⁷

Pictorial representation of how to operate these devices can be found in the inhalers’ package inserts.

Comparison of Inhalers

TABLE 1 summarizes the average wholesale prices of different inhalers on the U.S. market. Umeclidinium (Incruse Ellipta) is a LAMA monotherapy inhaler that provides a once-daily dosing option for patients as compared with aclidinium bromide (Tudorza Pressair), which is dosed twice daily.^14,15 With regard to LABA monotherapy inhalers, olodaterol (Striverdi Respimat) provides a once-daily dosing option for patients and is less expensive among other LABA monotherapies.¹⁶ Fluticasone furoate/vilanterol (Breo Ellipta) is a once-daily LABA/ICS combination inhaler.¹⁸ Note that fluticasone furoate/vilanterol received a new warning in January 2019 for both increased intraocular pressure and risk of glaucoma as well as hyperglycemia, which warrants additional monitoring in those with a history of type 2 diabetes mellitus.¹⁸

The 2019 GOLD guidelines include the once-daily LABA/LAMA/ICS combination inhaler fluticasone/umeclidinium/vilanterol. In addition to its appearance in the 2019 GOLD guidelines, a new warning was placed in the fluticasone/umeclidinium/vilanterol’s package insert for patients with narrow-angle glaucoma. Glaucoma, increased intraocular pressure, and cataracts have been reported with use of fluticasone/umeclidinium/vilanterol. Patients should report to a healthcare provider any eye pain or discomfort, blurred vision, or visual halos while using fluticasone/umeclidinium/vilanterol.¹³ These monotherapy and combination inhalers were introduced to the market within the past decade and vary in their costs and device technique.

Conclusion

There are a variety of inhalers for the treatment of COPD such as SABA, LABA, SAMA, LAMA, ICS, and combinations of these. First-line therapies are dependent upon a patient’s GOLD classification, as well as other patient-specific factors such as cost and type of inhaler. Also included in the 2019 GOLD update is a triple combination-therapy inhaler, fluticasone/umeclidinium/vilanterol (Trelegy Ellipta), which provides a once-daily option for patients with more severe COPD. There are several other monotherapy and combination inhalers that provide the option for once-daily dosing, which may be favorable for patients. Novel inhalers released within the past decade vary in cost and dosing frequency. These provide patients with more options to treat their COPD based on individual preferences. Inhalers used in the treatment of COPD are generally well tolerated. It is important for the pharmacist to assess inhaler technique and understand how each inhaler is used with each follow-up or encounter with patients. Other strategies to manage COPD include the pneumococcal vaccine, yearly influenza vaccine, and smoking cessation. COPD inhaler therapy should be individualized based on cost, patients’ preference, and their COPD classification.

REFERENCES

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5. Wedzicha JA, Decramer M, Ficker JH, et al. Analysis of chronic obstructive pulmonary disease exacerbations with the dual bronchodilator QVA149 compared with glycopyrronium and tiotropium (SPARK): a randomised, double-blind, parallel-group study. Lancet Respir Med. 2013;1(3):199-209.
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17. Utibron Neohaler (glycopyrronium/indacaterol) package insert. East Hanover, NJ: Novartis; 2015.
18. Breo Ellipta (vilanterol/fluticasone furoate) package insert. Research Triangle Park, NC: GlaxoSmithKline; 2013.
19. Anoro Ellipta (umeclidinium/vilanterol) package insert. Research Triangle Park, NC: GlaxoSmithKline; 2013.
20. Stiolto Respimat (tiotropium/olodaterol) package insert. Ridgefield, CT: Boehringer Ingelheim; 2015.
21. Bevespi Aerosphere Glycopyrronium/formoterol package insert. Wilmington, DE: AstraZeneca; 2016.
22. Red Book Online [database on Internet]. Greenwood Village (CO): Truven Health Analytics. www.micromedexsolutions.com. Accessed March 24, 2019.

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DuoResp Spiromax® – the new intuitive metered-dose powder inhaler for budesonide and formoterol | Wiesel

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8. Lähelmä S., Sairanen U., Haikarainen J.et al. Equivalent lung dose and systemic exposure of budesonide / formoterol combination via Easyhaler and Turbuhaler. J. Aerosol. Med. Pulm. Drug Deliv. 2015; 28 (6): 462-473.

9. Latorre M., Novelli F., Vagaggini B. et al. Differences in the efficacy and safety among inhaled corticosteroids (ICS) / long-acting beta2-agonists (LABA) combinations in the treatment of chronic obstructive pulmonary disease (COPD): Role of ICS.Pulm. Pharmacol. Ther. 2015; 30: 44-50.

10. Hozawa S., Terada M., Haruta Y., Hozawa M. Comparison of early effects of budesonide / formoterol maintenance and reliever therapy with fluticasone furoate / vilanterol for asthma patients requiring step-up from inhaled corticosteroid monotherapy. Pulm. Pharmacol. Ther. 2016; 37: 15-23.

11.Kew K.M., Karner C., Mindus S.M., Ferrara G. Combination formoterol and budesonide as maintenance and reliever therapy versus combination inhaler maintenance for chronic asthma in adults and children. Cochrane Database Syst. Rev. 2013; 12: CD009019.

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13. Scichilone N., Benfante A., Bocchino M. et al. Which factors affect the choice of the inhaler in chronic obstructive respiratory diseases? Pulm. Pharmacol. Ther. 2015; 31: 63–67.

14. Cohen J.S., Miles M.C., Donohue J.F., Ohar J.A. Dual therapy strategies for COPD: the scientific rationale for LAMA + LABA.Int. J. Chron. Obstruct. Pulm. Dis. 2016; 11: 785-797.

15. Laube B.L., Janssens H.M., de Jongh F.H.C. et al. What the pulmonary specialist should know about the new inhalation therapies: ERS / ISAM task force report. Eur. Respir. J. 2011; 37 (6): 1308-1331.

16. Wilson D.S., Gillion M.S., Rees P.J. Use of dry powder inhalers in COPD.Int. J. Clin. Pract. 2007; 61 (12): 2005-2008.

17. Wieshammer S., Dreyhaupt J. Dry powder inhalers: Which factors determine the frequency of handling errors? Respiration. 2008; 75: 1 8-25.

18. Melani A. S., Bonavia M., Cilenti V. et al. Inhaler mishandling remains common in real life and is associated with reduced disease control.Respir. Med. 2011; 105 (6): 930-938.

19. Basheti I.A., Obeidat N.M., Ammari W.G., Reddel H.K. Associations between inhaler technique and asthma control among asthma patients using pressurized MDIs and DPIs. Int. J. Tuberc. Lung Dis. 2016; 20 (5): 689–695.

20. Kondo T., Tanigaki T., Hibino M. et al. Resistances of dry powder inhalers and training whistles and their clinical significance.Arerugi. 2014; 63 (10): 1325-1329.

21. Wolthers O.D., Shah T.A Comparison of short-term growth during treatment with two dry powder combinations of inhaled corticosteroids and long-acting β₂-agonists. J. Aerosol Med. Pulm. Drug Deliv. 2015; 28 (3): 182-188.

22. Canonica G.W., Arp J., Keegstra J.R., Chrystyn H. Spiromax, a new dry powder inhaler: dose consistency under simulated real-world conditions.J. Aerosol. Med. Pulm. Drug Deliv. 2015; 28 (5): 309-319.

23. Virchow J. C., Rodriguez-Roisin R., Papi A. et al. A randomized, double-blinded, double-dummy efficacy and safety study of budesonide-formoterol Spiromax® compared to budesonide-formoterol TurbuhalerR in adults and adolescents with persistent asthma. BMC Pulm. Med. 2016; 16: 42.

24.Azouz W., Chetcuti P., Hosker H. et al. Inhalation characteristics of asthma patients, COPD patients and healthy volunteers with the Spiromax # R and Turbuhaler® devices: a randomized, cross-over study. BMC Pulm. Med. 2015; 15: 47.

25. Plusa T. Pijos P. Features of the ideal inhaler in testing a new inhaler devices. Int. Rev, Allergol. Clin. Immunol. Familiy Med. 2015; 21 (1): 21-24.

26.Sandler N., Holländer J., Långström D. et al. Evaluation of inhaler handling-errors, inhaler perception and preference with Spiromax, Easyhaler and Turbuhaler devices among healthy Finnish volunteers: a single site, single visit crossover study (Finhaler). Br. Med. J. Open Respir. Res. 2016; 3 (1): e000119.

27. Chrystyn H., Safioti G., Keegstra J.R., Gopalan G. Effect of inhalation profile and throat geometry on predicted lung deposition of budesonide and formoterol (BF) in COPD: An in-vitro comparison of Spiromax with Turbuhaler.Int. J. Pharm. 2015; 491 (1-2): 268-276.

28. Torvinen S., Nicolai J., Pulimeno S. et al. The budget impact of Duoresp® Spiromax® compared with commonly prescribed dry powder inhalers for the management of asthma and chronic obstructive pulmonary disease in Italy: estimated impact of inhalation technique. Value Health. 2015; 18 (7): A496.

90,000 COPD – chronic obstructive pulmonary disease

2019.12.17

Chronic obstructive pulmonary disease is a progressive and fatal disease

Chronic obstructive pulmonary disease (COPD) is a disease characterized by progressive incomplete airway obstruction (narrowing of air flow in the lungs, resulting in insufficient oxygenation of all tissues and organs) associated with an abnormal inflammatory response of the lungs to inhaled harmful particles or gases.in particular, smoking tobacco. The most important risk factor for COPD is long-term smoking. The onset of the disease is also influenced by environmental pollution and work in polluted (dusty or smoky) environments, a history of frequent respiratory infections and, in very rare cases, a deficiency of a certain protein (alpha-1-antitrypsin).

Data from various studies show that morbidity and mortality from COPD is increasing every year. In Europe, the incidence of this disease ranges from 5% to 10%, especially among the elderly.COPD is currently the fourth highest mortality rate, but according to WHO projections for 2030. it will become the third leading cause of death in the world (cardiovascular diseases will remain in first place, and oncology – in second). COPD is a progressive disease, which means that if left untreated, it will get worse and the changes will be irreversible. COPD often exacerbates the course of comorbidities and surgeries, and is often associated with depression, heart disease, skeletal muscle atrophy, decreased endurance, wasting, chronic heart disease, secondary polycythemia (an increase in the number of blood cells), and lung cancer.

COPD-specific symptoms

• Shortness of breath and shortness of breath. This occurs initially during increased physical activity, such as rushing to the bus or climbing stairs, and then, during simple daily activities (cleaning the house, getting dressed), and finally sitting or lying in bed;
• Cough of various types, cough, especially in the morning. A smoker usually associates cough with smoking, gets used to coughing in the morning, so he often does not notice that the cough has changed, has become constant and phlegm has appeared;
• Sputum regeneration.The sputum tends to be mucous and elongated, with exacerbation of the disease and the involvement of a purulent infection;
• Increased fatigue, general weakness;
• General respiratory infections;
• Weight loss, etc.

Diagnosis and treatment of COPD

Chronic obstructive pulmonary disease is diagnosed by a pulmonologist (pulmonologist) who assesses the patient’s complaints, has a medical history, clinical examination and spirometry.Lung volume and airflow rate during expiration are measured using spirometry. Patients with COPD have a reduced expiratory flow rate, which results in not all air being expelled from the lungs, and eventually emphysema (in other words, a “bulge”) develops, and the chest resembles a barrel.

After the diagnosis of COPD is made, treatment is carried out. Unfortunately, there is still no cure for chronic obstructive pulmonary disease, but following a doctor’s recommendations can slow its progression and improve quality of life, reduce the risk of death, and prevent flare-ups.

The earlier the disease is diagnosed, the easier it is to progress and the easier the treatment is. When diagnosing mild COPD, it is enough to follow the doctor’s recommendations and use fast-acting bronchodilators for shortness of breath. However, for the treatment of chronic obstructive pulmonary disease, inhaled bronchodilators are selected by the pulmonologist individually for each patient. In addition to the correct use of inhaled medications (inhalers), the advice of another doctor should be followed.

Doctor’s recommendations for patients

• Do not smoke because smoking continues to impair lung function and medications are less effective.
• Food is healthy and balanced: Eat 3-4 times a day, eat plenty of fresh foods, fruits and vegetables, and limit alcohol consumption.
• Maintain physical activity and improve your fitness: 20 to 30 minutes of aerobic exercise at least 2-3 times a week – especially Nordic walking, climbing stairs.For those who do not like active sports, walking in nature with a pet, playing with children or grandchildren can be a pleasant physical activity. A fast-acting bronchodilator can be inhaled before exercise.
• Overweight is recommended for those who are overweight, as weight loss will significantly increase physical performance and reduce shortness of breath.
• Avoid colds, always wear appropriate clothing for the season and keep the temperature below 19 degrees
• Prevention of viral respiratory infections from sick loved ones, since any respiratory infection can make breathing difficult and further damage lung tissue, and viral and bacterial respiratory infections are the most common cause of exacerbation of COPD.
• If your home has a runny nose or cold, it is recommended that you use disposable masks and wash your hands frequently.
• Influenza and pneumonia can be protected by vaccinations, which are free of charge to patients with the disease and must be administered annually as soon as the fall season begins.
• The correct use of drugs (inhalers) is very important for respiratory diseases, otherwise they will not enter the lower respiratory tract and will be ineffective. After inhalation treatment, your pulmonologist will teach you how to use them correctly and give you detailed instructions on how to use your inhaler.If you do not feel any improvement or feel that your medicines are not working, read the directions carefully or ask your pharmacist for advice.

When to call a pulmonologist?

A visit to a pulmonologist for chronic obstructive pulmonary disease is recommended at least once a year, for patients with severe COPD – 3 times a year. During the visit, pulmonary function and changes during treatment are assessed and the inhaler technique is explained.An appointment with a pulmonologist is also recommended if the prescribed treatment does not improve. During the consultation, the doctor will select the most appropriate medication and inhaler.

If you are over 40, complain of shortness of breath with mild to moderate exertion, shortness of breath accompanied by morning cough, phlegm, “shortness of breath”, changes in breathing patterns, shortness of breath, increased breathing and heart rate, especially if you smoke Visit your pulmonologist for a check spirometry to see if you have obstructive pulmonary disease.

Collaboration between patient and doctor is essential to the success of COPD treatment

Following the doctor’s recommendations and regular use of the drug can help stop the progression of the disease, maintain the ability to work longer, and continue a full-fledged social life. However, the patient’s own attitude and efforts are very important here. Failure to comply with the regimen and treatment will worsen the condition and cause irreversible changes. In more severe stages of COPD, physical activity is significantly reduced, and even seemingly light activities such as dressing or washing are questioned.Such patients may receive continuous oxygen therapy as determined by the pulmonologist who performed pulse oximetry and arterial blood gas monitoring.

Portable oxygen for chronic obstructive pulmonary disease

Relevance

Some people with chronic obstructive pulmonary disease (COPD) have low blood oxygen levels at rest or during exercise. Low oxygen levels are known as hypoxemia.These patients can carry a supply / source of oxygen (oxygen in small cylinders, portable liquid oxygen systems or battery operated oxygen concentrators) so they have oxygen to breathe to perform simple tasks such as changing clothes, getting out of the house, do household chores, or even make it easier to walk around their own home and help them breathe. This portable oxygen device is called “ambulatory oxygen”.

Review Question

We conducted this review to investigate the long-term benefits of ambulatory oxygen therapy in people who do not have severe resting hypoxemia.

Characteristics of research

We reviewed randomized controlled trials that compared ambulatory oxygen to placebo (regular air). We found four studies involving 331 people with a median age of 71. Two of the included studies were from Australia, one from New Zealand and one from Canada. The oxygen delivery method and oxygen dose were varied, although the equipment in all cases consisted of lightweight or portable cylinders with an oxygen flow of 3 L / min to 6 L / min.The final follow-up was 12 weeks in the three studies and two weeks in the Nonoyama study.

Main results

We found that ambulatory oxygen therapy reduced shortness of breath and decreased the number of patients who felt tired. However, the distance that people could walk in 5-6 minutes and the survival rate (death rate) did not change.

Quality of evidence: Overall, the quality of evidence in the studies included in this review was moderate [moderate].Research methods [how the research was carried out] were not fully presented in all cases. Most of the studies did not have a pre-published study plan (protocol).

Total

It is not possible to know from this review whether ambulatory oxygen therapy should be used / provided during exercise or daily activity / activity in patients with COPD who do not have severe hypoxemia at rest.

This Cochrane Summary is current to November 2012.

90,000 A way has been found in Britain to accelerate the treatment of COVID-19

UK Deputy Health Secretary Joe Churchill said using an asthma inhaler could help coronavirus patients. This is evidenced by preliminary data from a study conducted by the British authorities. Churchill noted that inhaled budesonide is not currently recommended as a treatment standard.

As shown by a preliminary study of scientists from the UK, the use of asthma inhalers can help patients with coronavirus – the recovery time is reduced by an average of three days. This was stated by Deputy Minister of Health Joe Churchill during a speech in the British Parliament, reports The Telegraph.

According to her, the study showed that the treatment time is shortened by inhalation of budesonide, a medicine used for asthma and chronic obstructive pulmonary disease.At the same time, Churchill stressed that the conclusions are based only on intermediate research results, and “a full analysis is currently being carried out to understand all the consequences of this treatment.”

“Clinical guidelines have been issued for physicians to prescribe inhaled budesonide on an individual basis, but inhaled budesonide is currently not recommended as the treatment standard in the UK,” the politician added.

She stressed that the recommendations would be adjusted as necessary when more detailed data became available.

Sir Graham Brady, a senior British official at COVID-19 headquarters, said he first considered using inhalers after a physician told him that very few coronavirus patients with asthma were admitted to hospitals. …

Last month, the European Medicines Regulator (EDQM) reported that there is still little evidence from experts that the use of inhaled corticosteroids in COVID-19 patients alleviates and shortens the course of the disease, Reuters reports.

In April of this year, the Center for Biomedical Research of the British National Institute of Medicine and the Anglo-Swedish pharmaceutical company AstraZeneca conducted an experiment in Oxfordshire on the use of inhalers for COVID-19, which was approved by the Fulham Research Ethics Committee of London and the National Office for Medical Research.

Participants in one group received budesonide, two inhalations twice a day, while other patients in the parallel group received conventional treatment for 7 days after the onset of mild symptoms of COVID-19.

As a result, scientists came to the conclusion that the introduction of inhaled budesonide reduced the likelihood of a need for urgent medical attention and shortened the recovery time from COVID-19. The research is described in the journal Lancet.

Earlier it was reported that asthmatics themselves tolerate a new type of coronavirus more easily, but not because of the use of inhalers, but because of the properties of the pathology itself, noted the head of the Department of Clinical Immunology and Allergology and the International Laboratory of Immunopathology of Sechenov University, Academician of the Russian Academy of Sciences Alexander Karaulov.

In an interview with Izvestia, he said that among comorbid patients with COVID-19, asthma is much less common than usual in the population, sometimes even twice or three times less often.

“That is, asthma may be a protective factor against coronavirus. One of the reasons for this is a special type of inflammation that all allergy sufferers have, Th-2-mediated. Perhaps it is the polarization of the immune response in this direction that protects patients with allergic asthma from severe course and death, ”the scientist said.

90,000 Expectations for a drug for the treatment of COPD were overestimated

Laboratorios Almirall, S.A. (Spain) and “Forest Laboratories, Inc.” (USA) announced the results of two phase III trials of a once-daily drug aclidinium bromide. Compared to placebo, aclidinium significantly improved lung function in patients with COPD, as measured by FEV1, which was the primary endpoint. However, as noted by the executive director of research and development of the Spanish company Per-Olof Andersson (Per-Olof Andersson), the severity of the bronchodilatory effect in both studies was less than in previous ones.Almirall and Forest are working hard to fully understand these results and determine the most beneficial dosing regimen, he said.

In response to this statement, the value of the shares of the American company fell by almost 14%, and the Spanish – by 42%. In October, P.-O. Andersson at the analyst conference, the companies will decide on the next steps and the need for other clinical trials, Bloomberg reported.

Aclidinium Bromide is a new, long-acting anticholinergic bronchodilator jointly developed by Almirall and Forest.The American company has licensed the rights to Aclidinium in the United States, while Almirall owns the rights to it in all other countries. The drug is applied using the new modern multi-dose powder inhaler Genuair ^® . The Genuair ^® is equipped with an intuitive feedback system that, with a colored control window, click and sweet taste, allows you to ensure that inhalation is correct. The inhaler contains 30 doses, has a residual level indicator and protective mechanisms to prevent accidental administration of a double dose and the use of an empty device.n

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90,000 The main cause of COPD is smoking

World COPD (Chronic Obstructive Pulmonary Disease) Day is celebrated in the second half of November. Often, people only become aware of the condition when coughs, difficulty breathing, and wheezing in the lungs become unbearable. Irina Pavlovna Beloglazova, a pulmonologist, head of the 4th therapeutic department of the City Clinical Hospital No. 52 , explains why COPD is dangerous, how it occurs, why it should not be treated. The doctor emphasizes that smoking is the main risk factor for developing COPD. Knowing about the consequences of an insidious disease, perhaps, will help someone get rid of a bad habit.

The abbreviation COPD has become increasingly common lately. However, we know little about this disease.

Chronic obstructive pulmonary disease (COPD) was identified as a separate disease only at the very end of the twentieth century.The manifestations of COPD and bronchial asthma are similar, but the nature of the diseases is different. Now we know more about the specifics of COPD and use special methods for its diagnosis and treatment. Understanding the characteristics of the development of the disease helps the doctor monitor the patient’s condition. Specialist supervision is important – COPD can lead to very serious consequences.

Why is COPD dangerous? How does it arise?

The word “obstruction” means a hindrance, an obstacle. In both bronchial asthma and COPD, the lumen of the bronchi narrows, which prevents the normal passage of air into the lungs.As a result, shortness of breath, coughing, shortness of breath, wheezing, choking occurs. In asthma, narrowing of the bronchi is the body’s immune response to an allergen irritant that has entered the bronchi. Then (for example, after a person has breathed with an inhaler), the lumen of the bronchus expands again, and the unpleasant symptoms disappear. Asthma is a well-controlled disease with reasonable patient behavior. The situation is different with COPD.

If you look at the bronchus in an electron microscope, you can see the epithelium (mucous membrane) with villi that move, expelling everything unnecessary outside and cleansing the lungs.If the villi are damaged, cleaning does not occur or is insufficient. Then the bronchial wall itself is damaged, it becomes thick and rigid. The narrowing of the bronchi in COPD, in contrast to asthma, is an irreversible process.

COPD is a very insidious disease. Most asthmatics, if they take care of themselves, do not face respiratory failure with age. In COPD, the process of damage to the bronchi and lungs continues. When the air passes the point where the bronchus is already constricted, expiratory collapse is possible: air cannot completely leave the lungs.As a result, the lung tissue stretches, loses its elasticity, begins to gradually collapse, which is accompanied by the appearance of bullae (air bubbles) and the development of emphysema. The patient’s lungs are over-inflated. This not only interferes with normal breathing, but also contributes to the development of pathological processes in the organs of the respiratory and other systems, since everything in the body is interconnected.

What are the causes of the disease?

Smoking is the main cause of COPD.The impact of combustion products on the bronchial wall leads to its changes. A smoker is very likely to develop COPD. Those who smoke and are not afraid of cancer should definitely be afraid of COPD. Studies show that mortality from respiratory failure due to lung cancer is approximately 20%, due to COPD – more than 23%.

If the patient does not smoke, the doctor is more likely to suspect another illness. However, frequent stay in the area of ​​burning bio-raw materials is also a risk factor for COPD.An increased likelihood of getting sick is in cooks, in people who live or spend a lot of time in houses with stove heating, where combustion products can enter the air of the living room.

Why see a doctor? Many COPD patients do not.

People may not know the symptoms to look out for. Someone is afraid that the doctor will say not the most pleasant things. First of all, he will offer to quit smoking. Finding out that the disease is incurable is also not fun.However, the doctor, firstly, correctly diagnoses the disease. Not all obstructive disorders are manifestations of COPD or asthma; the cause can be both cancer and a viral infection. Secondly, the doctor will prescribe a treatment that will slow down the progression of COPD and the dire consequences with which people end up in the hospital.

When do patients with COPD end up in hospital?

It would be useful for smokers to look at patients with COPD who are forced to live with an oxygen pillow “in an embrace”.People with infectious exacerbations, fever, cough, purulent sputum, increased shortness of breath, and asthma attacks are admitted to hospitals. Over time, the disease turns into a stage when it is no longer possible to cope with it at home on your own. We try to convince patients, explain that they will simply have nothing to breathe, they will feel like a fish thrown ashore. You can scare a stroke and a heart attack, many, having learned that the threat is serious, quit smoking. COPD is less afraid, but in vain!

What are the first signs of the disease? When to see a doctor and how is COPD diagnosed?

The first sign of the disease is shortness of breath, which occurs first with intense, and then with normal physical activity.With the development of the disease, shortness of breath worries even at rest. Then there are signs of oxygen deficiency – hands, lips turn blue, sometimes even the appearance of nails and fingers changes. There may be whistling and buzzing sounds in the lungs.

People with shortness of breath do not always realize and admit that they have breathing problems – they seem to feel fine, they have to work, they don’t want to get sick. The doctor often manages to understand that there are problems only by leading questions. However, if a person has been smoking for over 20 years and has shortness of breath, COPD is very likely.All smokers over the age of 40 (considering that they start smoking at about 20 years old) need to do spirometry – a measurement of breathing parameters. One of the parameters calculated during spirometry – the Tiffno index – indicates the possible presence of irreversible bronchial obstruction. Obstruction can be caused by various reasons, and sometimes we ask the patient to come back for a second text after a year. However, if the Tiffno’s index is less than 70%, there is shortness of breath and the patient smokes, the diagnosis of COPD is not in doubt.Then, based on the remaining indicators of spirometry, we discuss the choice of inhalers for continuous use.

How is COPD treated?

As I said, you cannot completely stop the process, but you can slow it down significantly. This must be done without indulging yourself with examples of acquaintances who smoked all their lives and “lived to be 100 years old.” Each has its own genetics, for some, the process is slower, while for others it is very fast and leads to the need for constant oxygen therapy.

The main method of therapy for COPD, as well as for asthma, is inhalers.No droppers, no pills, but inhalers. They must be picked up by a doctor. But if in patients with asthma the effect of using an inhaler is felt almost immediately, then with COPD this is not the case. Patients need to understand that even if there are no fundamental changes, inhalers should still be used, this will help to delay oxygen therapy, avoid complications and reduce the risk of exacerbations of the disease.

If quitting smoking will help?

COPD develops on average after 20 years of smoking. If you quit smoking earlier, the disease can be avoided.If you quit smoking at the first sign of illness, changes can be slowed down. If COPD is diagnosed, it is imperative to give up the bad habit!

SIMBIKORT TURBUHALER instructions for use, price in pharmacies in Ukraine, analogues, composition, indications | SYMBICORT TURBUHALER powder for inhalation metered by the company “AstraZeneca”

pharmacodynamics. Mechanism of action and pharmacodynamic effects . Symbicort contains formoterol and budesonide, which have different mechanisms of action and exhibit an additive effect on reducing the frequency of asthma exacerbations.The mechanisms of action of both compounds are respectively discussed below.

Budesonide – GCS, which, when inhaled, exhibits a dose-dependent anti-inflammatory effect in the respiratory tract, leading to a decrease in the severity of symptoms and a decrease in the frequency of exacerbations of asthma. Inhaled budesonide causes less severe adverse events than systemic corticosteroids. The exact mechanism responsible for the anti-inflammatory effect of GCS is unknown.

Formoterol is a selective β2-adrenergic receptor agonist that, when inhaled, leads to rapid and prolonged relaxation of bronchial smooth muscles in patients with reversible airway obstruction.

Bronchodilator effect is dose-dependent, the drug begins to act within 1-3 minutes. The duration of action is at least 12 hours after a single dose.

Clinical efficacy and safety . BA . Clinical studies in adult patients have shown that the addition of formoterol to budesonide reduces the severity of AD symptoms, improves lung function and reduces the frequency of exacerbations. In two 12-week studies, the effect of budesonide / formoterol on pulmonary function was the same as that of budesonide and formoterol in random combination, and exceeded the effect of budesonide when used alone.All treatment groups used short-acting β2-adrenoceptor agonists as needed. Over time, no signs of a weakening of the anti-asthma effect were observed.

Two 12-week studies were conducted with the participation of pediatric populations, in which 265 children 6-11 years old received treatment with maintenance doses of budesonide / formoterol (2 inhalations of 80 μg / 4.5 μg / inhalation 2 times a day), and a β2 agonist – short-acting adrenergic receptors as needed.In both studies, there was an improvement in lung function and treatment was tolerated as compared to an appropriate dose of budesonide when used alone.

Chronic obstructive pulmonary disease (COPD) . Two 12-month studies evaluated the effect of the drug on pulmonary function and the incidence of exacerbations (as measured by the number of courses of oral steroids and / or courses of antibiotics and / or hospitalization) in patients with moderate to severe COPD.The inclusion criterion in both studies was the value of the forced expiratory volume in 1 s (FEV1) before the use of bronchodilator <50% of the predicted norm. The median FEV1 after the use of bronchodilators at the time of inclusion in the study was 42% of the predicted norm.

The mean number of exacerbations per year (as defined above) was significantly reduced in the budesonide / formoterol group compared with formoterol alone or placebo (mean incidence 1.4 versus 1.8-1.9 in the placebo / formoterol group).The mean number of days of oral corticosteroid use / patient over 12 months was slightly reduced in the budesonide / formoterol group (7–8 days / patient / year versus 11–12 and 9–12 days in the placebo and formoterol groups, respectively). As for changes in pulmonary function parameters, such as FEV1, the effectiveness of treatment with budesonide / formoterol did not exceed that of therapy with formoterol alone.

Pharmacokinetics. Suction. The fixed dose combination of budesonide and formoterol and the corresponding monopreparations were found to be bioequivalent given the systemic exposure of budesonide and formoterol, respectively.Despite this, after using Symbicort, there was a slight increase in cortisol suppression compared with the use of drugs alone. The difference was found to be insignificant in terms of clinical safety.

There are no signs of pharmacokinetic interaction of budesonide with formoterol.

The pharmacokinetic parameters of the respective substances were similar after the use of budesonide and formoterol in the form of monopreparations or as part of a combination of fixed doses of budesonide and formoterol.After using the fixed combination, the AUC of budesonide was slightly higher, the absorption rate and Cmax in the blood plasma were slightly higher than when the drugs were used alone. The Cmax of formoterol in blood plasma after the use of the fixed combination was similar to that of the monopreparation. Inhaled budesonide is rapidly absorbed; plasma concentration reaches a maximum within 30 minutes after inhalation. In studies, the average distribution of budesonide in the lungs after inhalation through a dry powder inhaler ranged from 32 to 44% of the dose received.Systemic bioavailability is about 49% of the dose received. In children and adolescents aged 6–16 years, deposits in the lungs were noted in the same interval as in adults at similar doses. Corresponding plasma concentrations have not been determined.

Inhaled formoterol is rapidly absorbed. The maximum plasma concentration is reached within 10 minutes after inhalation. In studies, the average distribution of formoterol in the lungs after inhalation through a dry powder inhaler ranged from 28 to 49% of the dose received.Systemic bioavailability is about 61% of the dose received.

Distribution and Metabolism. About 50% of formoterol and 90% of budesonide binds to blood plasma proteins. The volume of distribution of formoterol is about 4 l / kg, budesonide – 3 l / kg. Formoterol is deactivated by conjugation reactions (active O-demethylated and deformed metabolites are formed, but they exist mainly in the form of inactivated conjugates). Budesonide undergoes significant (up to about 90%) biotransformation during the first passage through the liver with the formation of metabolites with low GCS activity.

GCS activity of the main metabolites, 6-β-hydroxy-budesonide and 16-α-hydroxyprednisolone, does not exceed 1% of the similar activity of budesonide. There are no signs of metabolic interaction or substitution reactions between formoterol and budesonide.

Derivation. Most of the dose of formoterol undergoes hepatic metabolism and is subsequently excreted by the kidneys. After inhalation, 8-13% of the administered dose of formoterol is excreted unchanged in the urine. Formoterol has a high systemic clearance (approximately 1.4 l / min), its terminal T½ is 17 hours on average.

Budesonide is metabolized primarily by the CYP 3A4 enzyme. Budesonide metabolites are excreted in the urine unchanged or in conjugated form. Only a small amount of unchanged budesonide is determined in the urine. Budesonide has a high systemic clearance (approximately 1.2 L / min), its T½ after IV administration is approximately 4 hours.

The pharmacokinetics of budesonide or formoterol in children and patients with renal insufficiency is unknown. In patients with liver disease, the concentrations of budesonide and formoterol in the blood may be elevated.

Linearity / Non-linearity . Systemic exposure for budesonide and formoterol is in linear correlation with the dose applied.

Symbicort Turbuhaler 80 mcg / 4.5 mcg is indicated for use in adults, adolescents and children aged 6 years and older.

Symbicort Turbuhaler 80 mcg / 4.5 mcg is prescribed for regular treatment of asthma in case of expedient use of combination therapy (inhaled GCS and long-acting β2-adrenergic receptor agonist):

90,078 90,079 patients whose condition is insufficiently controlled with inhaled corticosteroids and fast-acting β2-adrenergic agonists, used as needed, or 90,080
90,079 patients whose condition is properly controlled by inhaled GCS and long-acting β2-adrenergic receptor agonists.

Symbicort Turbuhaler (80 mcg / 4.5 mcg / dose) is not prescribed for the treatment of patients with severe asthma.

Symbicort Turbuhaler 160 mcg / 4.5 mcg / Symbicort Turbuhaler 320 mcg / 9 mcg / is prescribed for adults and children over 12 years of age for regular treatment of asthma if it is advisable to use combination therapy (inhaled GCS and long-acting β2-adrenergic receptor agonist) :

90,078 90,079 patients whose condition is insufficiently controlled with inhaled corticosteroids and fast-acting β2-adrenergic agonists, used as needed, or 90,080
90,079 patients whose condition is properly controlled by inhaled GCS and long-acting β2-adrenergic receptor agonists.

Symbicort Turbuhaler 160 mcg / 4.5 mcg / Symbicort Turbuhaler 320 mcg / 9 mcg / is prescribed for symptomatic treatment in adult patients aged 18 years and older with forced expiratory volume in 1 s (FEV1) <70% of the predicted norm (after using a bronchodilator) and a history of exacerbations, despite regular therapy with bronchodilators.

Symbicort Turbuhaler 80 μg / 4.5 μg

Dosing

BA Symbicort Turbuhaler 80 mcg / 4.5 mcg is not prescribed for the initial treatment of asthma.

Doses of the components of the drug Symbicort Turbuhaler 80 mcg / 4.5 mcg are selected individually and must be adjusted based on the severity of the disease. This should be taken into account not only at the beginning of the use of combination drugs, but also when adjusting the maintenance dose. If the patient requires a combination of doses that differ from those available in the combined inhaler, appropriate doses of β2-adrenergic receptor agonists and / or corticosteroids should be prescribed in separate inhalers.

The dose should be titrated to the minimum that will effectively control the symptoms of the disease. Patients need to regularly undergo repeated examinations by the doctor who prescribed the drug so that the dose of Symbicort Turbuhaler 80 mcg / 4.5 mcg remains optimal. After achieving long-term control of symptoms using the minimum recommended dose, you should try to control symptoms only with inhaled corticosteroids.

There are two options for using the drug Symbicort Turbuhaler 80 mcg / 4.5 mcg.

A. For maintenance therapy. Symbicort is used for regular maintenance therapy in combination with a separate fast-acting bronchodilator used as an emergency.

B. For maintenance therapy and symptom relief. Symbicort Turbuhaler 80 mcg / 4.5 mcg is used for regular maintenance therapy, as well as, if necessary, to relieve symptoms.

A. Application of the drug Symbicort Turbuhaler 80 μg / 4.5 μg for maintenance therapy. Patients should be advised to carry a separate rapid-acting bronchodilator at all times for use as an emergency.

Recommended doses

Adults (over 18 years old) : 1-2 inhalations, 2 times a day. Some patients may need up to 4 inhalations 2 times a day

Adolescents (12-17 years old) : 1-2 inhalations, 2 times a day.

Children (over 6 years old) : 2 inhalations, 2 times a day.

Usually, after achieving control over the symptoms of the disease when using the drug 2 times a day, the dose is titrated to the minimum effective dose, up to the use of the drug Symbicort Turbuhaler 80 μg / 4.5 μg 1 time per day, in cases where, according to the doctor, the patient needs maintenance therapy with a long-acting bronchodilator in combination with an inhaled corticosteroid.

More frequent use of an additional fast-acting bronchodilator indicates a worsening of the patient’s condition and the need to revise BA treatment.

Children under 6 years of age: Symbicort Turbuhaler 80 mcg / 4.5 mcg is not recommended for use in children under 6 years of age.

B. Use of the drug Symbicort Turbuhaler 80 mcg / 4.5 mcg for maintenance therapy and to reduce the severity of symptoms.

Take a daily maintenance dose of the drug Symbicort Turbuhaler 80 mcg / 4.5 mcg, and in addition use Symbicort Turbuhaler 80 mcg / 4.5 mcg if it is necessary to reduce the severity of symptoms.Patients should be advised to always have Symbicort Turbuhaler 80 mcg / 4.5 mcg with them for immediate use.

The use of Symbicort Turbuhaler 80 μg / 4.5 μg for maintenance therapy and symptom relief should be considered, in particular in patients:

• with insufficient control of asthma, who often need drugs to reduce the severity of symptoms;
• with exacerbation of asthma in the past, which required medical intervention.

Patients who often and in large quantities use inhalation of Symbicort Turbuhaler 80 mcg / 4.5 mcg as needed should be carefully monitored for the development of dose-dependent adverse events.

Recommended doses

Adults and adolescents from 12 years old: The recommended maintenance dose is 2 inhalations per day – 1 inhalations in the morning and in the evening, or 2 inhalations only in the morning or only in the evening.If necessary, when symptoms appear, use 1 additional inhalation. If symptoms persist after a few minutes, an additional inhalation should be given. In any particular case, you should not use more than 6 inhalations.

Usually a total of no more than 8 inhalations are required per day; however, for a limited period, the total daily dose may be up to 12 inhalations. Patients taking more than 8 inhalations per day are strongly advised to see a doctor.They need to be reevaluated and re-evaluated on supportive care.

Children under 12 years of age: it is not recommended to use Symbicort Turbuhaler 80 mcg / 4.5 mcg for maintenance therapy and to reduce the severity of symptoms.

Symbicort Turbuhaler 160 μg / 4.5 μg

Dosing . BA . Symbicort Turbuhaler 160 mcg / 4.5 mcg is not prescribed for the initial treatment of asthma.

Doses of the components of the drug Symbicort Turbuhaler 160 mcg / 4.5 mcg are selected individually and must be adjusted based on the severity of the disease.This should be taken into account not only at the beginning of the use of combination drugs, but also when adjusting the maintenance dose. If the patient requires a combination of doses that differ from those available in the combined inhaler, appropriate doses of β2-adrenergic receptor agonists and / or corticosteroids should be prescribed in separate inhalers.

The dose should be titrated to the minimum that will effectively control the symptoms of the disease. Patients need to regularly undergo repeated examinations by the doctor who prescribed the drug so that the dose of Symbicort Turbuhaler 160 mcg / 4.5 mcg remains optimal.After achieving long-term control of symptoms using the minimum recommended dose, you should try to control symptoms only with inhaled corticosteroids.

There are two options for using the drug Symbicort Turbuhaler 160 mcg / 4.5 mcg.

A. Application of Symbicort Turbuhaler 160 mcg / 4.5 mcg for maintenance therapy. Symbicort Turbuhaler 160 mcg / 4.5 mcg is used for regular maintenance therapy in combination with a separate fast-acting bronchodilator used as an emergency treatment.

B. Application of the drug Symbicort Turbuhaler 160 mcg / 4.5 mcg for maintenance therapy and to reduce the severity of symptoms. Symbicort Turbuhaler 160 mcg / 4.5 mcg is used for regular maintenance therapy, as well as, if necessary, to reduce the severity of symptoms.

A. Application of the drug Symbicort Turbuhaler 160 μg / 4.5 μg for maintenance therapy .

Patients should be advised to always carry a separate fast acting bronchodilator for emergency use.

Recommended doses

Adults (over 18 years old) : 1-2 inhalations, 2 times a day. Some patients may need up to 4 inhalations 2 times a day

Adolescents (12-17 years old) : 1-2 inhalations, 2 times a day.

Children (over 6 years old) : 2 inhalations, 2 times a day.

Usually, after achieving control of the symptoms of the disease with the use of the drug 2 times a day, the dose is titrated to the minimum effective, up to the use of the drug Symbicort Turbuhaler 160 μg / 4.5 μg 1 time per day, in cases where, according to the doctor, the patient needs maintenance therapy with a long-acting bronchodilator in combination with an inhaled corticosteroid.

More frequent use of an additional fast-acting bronchodilator indicates a worsening of the patient’s condition and the need to revise BA treatment.

Children (over 6 years of age): A lower dose formulation is available for use in children 6–11 years of age (80 mcg / 4.5 mcg).

Children under 6 years of age: Because there are limited data, Symbicort Turbuhaler 160 mcg / 4.5 mcg is not recommended for use in children under 6 years of age.

B. Use of the drug Symbicort Turbuhaler 160 mcg / 4.5 mcg for maintenance therapy and to reduce the severity of symptoms.

Take a daily maintenance dose of the drug Symbicort Turbuhaler 160 mcg / 4.5 mcg, and in addition use Symbicort Turbuhaler 160 mcg / 4.5 mcg if it is necessary to reduce the severity of symptoms. Patients should be advised to always have Symbicort Turbuhaler 160 mcg / 4.5 mcg with them for immediate use.

The use of Symbicort Turbuhaler 160 mcg / 4.5 mcg for maintenance therapy and symptom relief should be considered, in particular in patients:

• with insufficient control of asthma, who often need drugs to reduce the severity of symptoms;
• with exacerbation of asthma in the past, which required medical intervention.

Patients who often and in large quantities use inhalation of Symbicort Turbuhaler 160 μg / 4.5 μg as needed should be carefully monitored for the development of dose-dependent adverse events.

Recommended doses

Adults and adolescents from 12 years old: The recommended maintenance dose is 2 inhalations per day – 1 inhalations in the morning and in the evening, or 2 inhalations only in the morning or only in the evening.If necessary, when symptoms appear, use 1 additional inhalation. If symptoms persist after a few minutes, an additional inhalation should be given. In any particular case, you should not use more than 6 inhalations.

Usually a total of no more than 8 inhalations are required per day; however, for a limited period, the total daily dose may be up to 12 inhalations. Patients taking more than 8 inhalations per day are strongly advised to see a doctor.They need to be reevaluated and re-evaluated on supportive care.

Children under 12 years of age: It is not recommended to use Symbicort Turbuhaler 160 mcg / 4.5 mcg for maintenance therapy and relief of symptoms.

COPD

Recommended doses . Adults: 2 inhalations 2 times a day.

Symbicort Turbuhaler 320 μg / 9 μg

Dosing . BA . Symbicort Turbuhaler 320 mcg / 9 mcg is not prescribed for the initial treatment of asthma.

Doses of the components of the drug Symbicort Turbuhaler 320 mcg / 9 mcg are selected individually and must be adjusted based on the severity of the disease. This should be taken into account not only at the beginning of the use of combination drugs, but also when adjusting the maintenance dose. If the patient requires a combination of doses that differ from those available in the combined inhaler, appropriate doses of β2-adrenergic receptor agonists and / or corticosteroids should be prescribed in separate inhalers.

Recommended doses

Adults (from 18 years old): 1 inhalation 2 times a day. Some patients may need up to 2 inhalations 2 times a day

Adolescents (aged 12-17 years): 1 inhalation 2 times a day.

Patients need to regularly undergo repeated examinations by the doctor who prescribed the drug so that the dose of Symbicort Turbuhaler 320 mcg / 9 mcg remains optimal. The dose should be titrated to the lowest dose that effectively controls the symptoms of the disease.After achieving long-term control of symptoms using the minimum recommended dose, you should try to control symptoms only with inhaled corticosteroids.

Usually, after achieving control of the symptoms of the disease when using the drug 2 times a day, the dose is titrated to the minimum effective dose, up to the use of the drug Symbicort Turbuhaler 80 mcg / 4.5 mcg 1 time per day, in cases where, according to the doctor, the patient needs in maintenance therapy with a long-acting bronchodilator in combination with an inhaled corticosteroid.

More frequent use of an additional fast-acting bronchodilator indicates a worsening of the patient’s condition and the need to revise BA treatment.

Children (6+ years of age): A lower dosage form is available for use in children 6-11 years of age (80 mcg / 4.5 mcg).

Children under 6 years of age: Because of limited data, Symbicort Turbuhaler 320 mcg / 9 mcg is not recommended for use in children under 6 years of age.

Symbicort 320 mcg / 9 mcg should not be used only for maintenance therapy. For maintenance therapy and reducing the severity of symptoms with Symbicort, there are dosage forms with a lower potency (160 μg / 4.5 μg / dose and 80 μg / 4.5 μg / dose).

COPD

Recommended doses . Adults : 1 inhalation 2 times a day.

General information

Special patient groups .There are no special dosage requirements in elderly patients. There are no data on the use of Symbicort in patients with impaired renal or hepatic function. Since budesonide and formoterol are excreted predominantly with the participation of hepatic metabolism, an increase in the effect of the drug can be expected in patients with severe liver cirrhosis.

Application

Instructions for the correct use of Symbicort Turbuhaler

Preparation of the new Symbicort Turbuhaler inhaler for use .Before the first use of the new Symbicort Turbuhaler inhaler, it must be prepared for work, as indicated below.

Unscrew and remove the cap of the inhaler. Noise may be heard.

Hold the Symbicort Turbuhaler inhaler vertically with the red dispenser facing down.

Turn the red dispenser all the way to one side, then also all the way to the other (it doesn’t matter which way to turn initially). There should be a click.

Turn the red dispenser again in both directions.

The Symbicort Turbuhaler inhaler is now ready to use.

How to inhale

To take a dose, the following instructions must be followed.

1. Unscrew and remove the cap. Noise may be heard.

2. Hold the Symbicort Turbuhaler inhaler vertically with the red dispenser facing down.

3. While filling the dose into the inhaler, do not hold it by the nozzle. To fill a dose into the inhaler, you need to scroll the dispenser all the way to one side (either), and then to the other.There should be a click. Inhaler Symbicort Turbuhaler is filled and ready to use. The inhaler should be refilled only before inhalation.

4. Without bringing the inhaler to your mouth, exhale calmly (as far as convenient). Do not exhale through the inhaler nozzle.

5. Carefully place the attachment between your teeth, compress your lips and inhale as deeply and forcefully as possible through your mouth. Do not chew or squeeze the attachment with your teeth.

6. Remove the inhaler from your mouth. Exhale calmly.

The amount of drug inhaled is very small.This means that the taste of the drug may not be felt after inhalation. Provided the instructions are followed, you can be sure that the dose has been taken and the drug has entered the lungs.

7. If you need to make another inhalation, repeat steps 2-6.

8. Close the cap tightly after using the inhaler.

9. After daily morning and / or evening inhalation, rinse your mouth with water without swallowing it.

Do not attempt to remove or unscrew the tip.It is attached to the Symbicort Turbuhaler inhaler and should not be removed. Do not use the inhaler if it is damaged or the nozzle has come off.

As with other inhalers, caregivers should ensure that children who are prescribed Symbicort Turbuhaler inhale in accordance with the above instructions.

Cleaning the inhaler Symbicort Turbuhaler . The outer surface of the nozzle should be wiped with a dry cloth once a week. Do not use water or other liquids.

When to use a new inhaler . The dose indicator shows how many doses (inhalations) are left in the Symbicort Turbuhaler inhaler. The countdown of doses of the filled inhaler starts from 60.

The indicator shows an interval of 10 doses. Therefore, he does not show every dose.

The appearance of a red color in the indicator window means that there are about 20 doses left in the inhaler. When 10 doses remain in the inhaler, the dose indicator window turns completely red.When the “0” mark on the red window reaches the center of the indicator window, you need to replace the inhaler with a new one.

Note: the dispenser will rotate and click even when the Symbicort Turbuhaler inhaler is empty.

The sound that can be heard when the Symbicort Turbuhaler inhaler is shaken is caused by a moisture absorber, not a drug. Therefore, this sound will not help determine how much drug is left in the Symbicort Turbuhaler inhaler.

If more than 1 dose is mistakenly filled into the Symbicort Turbuhaler inhaler, only 1 dose will still enter the lungs during inhalation.However, the dose indicator will record the total number of doses measured.

In case of exceeding the dose. The drug must be taken in accordance with the instructions or recommendations of a doctor. Do not exceed the recommended dose without talking to your doctor.

The most common symptoms that can occur if the dose of Symbicort Turbuhaler is exceeded are tremors, headache or heart palpitations.

In case of missed inhalation. If the inhalation has been missed, you need to do it immediately after remembering this. However, if there is little time left before the next inhalation, you do not need to take the missed dose.

Do not take a double dose to compensate for the missed dose.

For further questions on the use of the medicinal product, you should consult your doctor or pharmacist.

The drug in powder form enters the body with the air, which is inhaled. That is, when the patient inhales through the inhaler nozzle, the substance enters the respiratory tract along with the air that he inhales.

Note. It is important to instruct the patient:

• Observe the instructions for medical use;
• inhale strongly and deeply through the nozzle so as to ensure the optimal dose is delivered to the lungs;
• never exhale through the nozzle;
• after application, close Symbicort Turbuhaler with a cap;
• After inhaling the maintenance dose, rinse your mouth with water to minimize the risk of developing oral candidiasis.In the case of oral candidiasis, rinse your mouth with water also after using the drug, if necessary.

hypersensitivity to budesonide, formoterol or lactose (contains a small amount of milk proteins).

since Symbicort contains budesonide and formoterol, side effects may occur that develop when each of the compounds is used separately. The simultaneous use of both substances did not increase the frequency of adverse reactions.The most common adverse reactions are the pharmacologically putative effects of β2-adrenergic receptor agonists, such as tremors and palpitations. They are usually mild and go away after a few days of treatment.

The following adverse reactions caused by the use of budesonide or formoterol are given by classes of organ systems and the frequency of their manifestation. By the frequency of occurrence, adverse reactions are classified as follows: very often (≥1 / 10), often (from ≥1 / 100 to <1/10), infrequently (from ≥1 / 1000 to <1/100), rarely (from ≥ 1/10 000 to <1/1000) and very rarely (<1/10 000).

Oropharyngeal candidiasis is the result of deposition of the drug in the oral cavity.It is recommended to instruct the patient to rinse the mouth with water after each inhalation of the maintenance dose to minimize the risk of developing oral candidiasis. Oropharyngeal candidal infection usually responds to local antifungal treatment without the need to discontinue inhaled corticosteroids. In case of development of oropharyngeal candidiasis, rinse your mouth with water also after using the drug, if necessary.

As with any other inhalation therapy, it is very rare (<1 case per 10,000 patients) that paradoxical bronchospasm may develop with an immediate increase in wheezing and shortness of breath after taking the drug.Paradoxical bronchospasm, which should be started immediately, responds to the use of a fast-acting inhaled bronchodilator. In this case, you should immediately stop using Symbicort, assess the patient's condition and, if necessary, start alternative therapy (see SPECIAL INSTRUCTIONS).

Systemic effects can occur with inhaled use of corticosteroids, especially at high doses and over a long period of time. The likelihood of such effects is lower with the use of inhaled forms of corticosteroids compared with oral ones.Possible systemic effects include Cushing’s syndrome, cushingoid symptoms, adrenal suppression, growth retardation in children and adolescents, decreased bone mineral density, cataracts, and glaucoma. There may also be an increased susceptibility to infections and impaired ability to adapt to stress. Effects are likely to depend on the dose, exposure time, the effect of the combined and previously used steroid, and individual sensitivity.

Treatment with β2-adrenergic receptor agonists can lead to increased blood levels of insulin, free fatty acids, glycerol and ketone bodies.

The use of systemic and inhaled corticosteroids can lead to pneumonia or lower respiratory tract infection in patients with COPD and immunosuppression.

Pediatric Populations . It is recommended to regularly monitor the growth of children who use inhaled corticosteroids for a long time (see SPECIAL INSTRUCTIONS).

Reported suspected adverse reactions . Reports of suspected adverse reactions after drug registration are important.This allows you to continue monitoring the benefit / risk ratio of the drug. Health workers are asked to report any suspicious adverse reactions (reported nationally).

if it is necessary to stop treatment, it is recommended to gradually reduce the dose, and not abruptly cancel the therapy.

If, in the patient’s opinion, the treatment is ineffective, or if the maximum daily dose of Symbicort is exceeded, the patient should be strongly advised to consult a doctor (see.APPLICATION). More frequent use of an additional fast-acting bronchodilator indicates a worsening of the patient’s condition and the need to revise BA treatment. A sudden and progressive deterioration in the control of asthma or COPD is potentially life-threatening, therefore, the patient should definitely undergo a medical examination. In such cases, consideration should be given to the need to intensify corticosteroid therapy, for example, prescribe a course of oral corticosteroids or additional antibiotics if a concomitant infection occurs.

The patient should be advised to always have an inhaler with him as a means of assistance: either Symbicort (for patients with asthma who use Symbicort as maintenance therapy and reduce the severity of symptoms), or another fast-acting bronchodilator (for all patients who use Symbicort only for maintenance therapy).

Patients should be reminded of the need to continue the maintenance use of Symbicort as prescribed, even if they are asymptomatic.

Once asthma symptoms are under control, a gradual reduction in Symbicort dose may be considered. It is important that the patient undergoes regular check-ups. The minimum effective dose of Symbicort should be used (see APPLICATION).

Symbicort therapy should not be started during an exacerbation of asthma, acute manifestation or significant deterioration of its course.

During the period of application of Symbicort, serious adverse events caused by asthma may occur or worsen.Patients should continue treatment and consult a doctor if symptoms persist or worsen after starting Symbicort therapy.

There are no data from clinical studies on the use of Symbicort Turbuhaler in patients with COPD with an FEV1 value before bronchodilator use> 50% of the predicted norm and with FEV1 after bronchodilator use <70% of the predicted norm.

As in the case of other inhalation drugs, paradoxical bronchospasm may occur immediately after using the drug, with increased wheezing and dyspnea after using a dose of the drug.In this case, you should stop using Symbicort, assess the patient’s condition and, if necessary, start alternative therapy. Paradoxical bronchospasm, which should be started immediately, responds to the use of a fast-acting inhaled bronchodilator (see SIDE EFFECTS).

Systemic effects can occur with inhaled use of all corticosteroids, especially at high doses and over a long period of time. The likelihood of such effects is lower with the use of inhaled forms of corticosteroids compared with oral ones.Possible systemic effects include Cushing’s syndrome, cushingoid symptoms, suppression of adrenal function, stunted growth in children and adolescents, decreased bone mineral density, cataracts and glaucoma, less often mental disorders or behavioral changes, including psychomotor hyperactivity, sleep disturbance, anxiety, depression or aggression (especially in children) (see SIDE EFFECTS).

Possible effects on bone mineral density should be considered, especially in patients taking the drug in high doses for a long period, which is an additional risk factor for osteoporosis.In long-term studies of inhaled budesonide with an average daily dose of 400 mcg (metered dose) in children or 800 mcg (metered dose) in adults, no significant effect on bone mineral density has been reported. There is no information on the effect of Symbicort at higher doses.

If there is reason to believe that adrenal function was impaired against the background of previous systemic steroid therapy, precautions should be taken when transferring patients to Symbicort treatment.

The benefits of inhaled budesonide therapy generally minimize the need for oral steroids, but patients who have previously used oral steroids may still be at risk of adrenal dysfunction for a significant period of time. Patient recovery after stopping oral steroids can take a long time and, therefore, patients who have previously used oral steroids and have been switched to inhaled budesonide treatment due to adrenal dysfunction may remain at risk for a significant period of time.Under these circumstances, the function of the hypothalamic-pituitary-adrenal system should be monitored regularly.

Long-term treatment with inhaled corticosteroids in high doses, especially in the case of using doses higher than recommended, can also lead to clinically significant suppression of adrenal function. Therefore, it is necessary to provide for additional systemic use of corticosteroids during periods of stress (for example, in severe infectious diseases) or planned surgery.A rapid decrease in the dose of steroids can lead to the development of acute adrenal insufficiency. Symptoms and signs that may occur with acute adrenal insufficiency may be somewhat vague, but may include anorexia, abdominal pain, weight loss, fatigue, headache, nausea, vomiting, decreased consciousness, seizures, hypotension, and hypoglycemia …

Treatment with additional systemic steroids or inhaled budesonide is not recommended abruptly.

When switching from oral steroid therapy to Symbicort, there will generally be a lower systemic exposure to steroids and this can lead to allergic or arthritis symptoms such as rhinitis, eczema, and muscle and joint pain. If these conditions develop, it is necessary to start specific treatment. Insufficiency of GCS action should be suspected if, in rare cases, symptoms such as fatigue, headache, nausea and vomiting occur.In these cases, a temporary increase in the dose of oral corticosteroids is sometimes necessary.

To reduce the risk of developing oropharyngeal candidiasis (see SIDE EFFECTS), the patient should be instructed to rinse the mouth with water after each maintenance dose.

The concomitant use of itraconazole, ritonavir, or other potent CYP 3A4 inhibitors should be avoided (see INTERACTIONS). If this is not possible, the interval between the use of interacting drugs should be as long as possible.

Symbicort should be used with caution in patients with thyrotoxicosis, pheochromocytoma, diabetes mellitus, uncontrolled hypokalemia, hypertrophic obstructive cardiomyopathy, idiopathic subvalvular aortic stenosis, severe hypertension, aneurysm or other severe heart disease such as coronary artery disease.

The drug should be used with caution in patients with prolongation of the interval Q – Tc .Formoterol alone can cause prolongation of the Q – Tc interval.

The need for the use of inhaled corticosteroids and their dose in patients with active or latent pulmonary tuberculosis, fungal or viral infections of the respiratory tract should be reviewed.

With the use of β2-adrenergic receptor agonists in high doses, the development of potentially serious hypokalemia is possible. With combined treatment with β2-adrenergic receptor agonists and drugs that can cause hypokalemia or enhance the hypokalemic effect (for example, xanthine derivatives, steroids and diuretics), the hypokalemic effect of β2-adrenergic receptor agonists may increase.Particular care should be taken in patients with unstable asthma when using various immediate-acting bronchodilators, in acute severe asthma, since the risk of developing hypokalemia increases against the background of hypoxia and other conditions that increase the likelihood of developing such a complication as hypokalemia. In such cases, it is recommended to monitor serum potassium levels.

As with the use of other β2-adrenergic receptor agonists, blood glucose levels should be additionally monitored in patients with diabetes mellitus.

Symbicort Turbuhaler contains lactose monohydrate (<1 mg per 1 inhalation). Usually this amount does not cause problems in patients who are lactose intolerant. This excipient contains small amounts of milk proteins, which may cause allergic reactions.

Pneumonia and other lower respiratory tract infections . Physicians should be careful about the possible development of pneumonia in patients with COPD, given the frequent overlap of clinical signs of pneumonia and exacerbation of the underlying disease.Lower respiratory tract infections, including pneumonia, have occurred following inhaled corticosteroid use.

Immunosuppression . Patients who take drugs that suppress the immune system are more susceptible to infection than healthy people.

Pneumonia in patients with COPD . In patients with COPD who received inhaled corticosteroids, there was an increased incidence of pneumonia, including cases of pneumonia requiring hospitalization.There is some evidence of an increased risk of pneumonia with increasing doses of steroids, but this has not been demonstrated reliably in all studies.

There is no convincing clinical evidence of intraclass differences in the risk of developing pneumonia between inhaled corticosteroid drugs.

Physicians should be careful about the possible development of pneumonia in patients with COPD, since the clinical signs of infections are comparable to those of an exacerbation of COPD.

Risk factors for pneumonia in patients with COPD include smoking, old age, low body mass index, and severe COPD.

Pediatric Populations . It is recommended to regularly monitor the growth of children using long-term inhaled corticosteroids. If their growth slows down, therapy should be revised in order to reduce the dose of inhaled corticosteroids to the minimum, at which effective BA control is maintained, if possible. The benefits of corticosteroids and the potential risk of growth retardation must be carefully weighed.In addition, it may be advisable to refer the patient to a pediatric pulmonologist for examination.

Based on the limited data from studies on long-term GCS treatment, it can be assumed that most children and adolescents receiving inhaled budesonide therapy will eventually achieve normal adult growth rates. However, there was an initial slight and temporary lag in growth (about 1 cm). Typically, this delay occurs in the first year of treatment.

The period of pregnancy and lactation. Pregnancy. There are no clinical data on the use of Symbicort or the combined use of formoterol and budesonide during pregnancy.

The data obtained during the study of the effect of this combination on the embryofetal development of rats did not show any signs of any additional effect when using the combination.

There are no sufficient data regarding the use of formoterol in pregnant women.In studies of reproductive function in animals, formoterol caused the development of undesirable effects when used in very high systemic doses.

The data obtained from the observation of about 2000 pregnancies did not reveal any increase in teratogenic risk associated with the use of inhaled budesonide. Animal studies have shown that GCS can cause developmental disorders. However, these data are probably not considered significant for humans when using the drug at the recommended doses.

During animal studies, it was also revealed that the use of glucocorticoids during pregnancy in high doses increased the risk of intrauterine growth retardation, the development of cardiovascular diseases in adult animals and led to permanent changes in the density of glucocorticoid receptors, metabolism and the profile of neurotransmitters in the case of the use of drugs in the dose range below teratogenic.

During pregnancy Symbicort should be used if the benefit to the mother outweighs the potential risk to the fetus / child.The minimum effective dose of budesonide should be used, which ensures proper control of asthma.

Breastfeeding . Budesonide passes into breast milk. However, when the drug is taken in therapeutic doses, the effect on the infant is not expected. It is not known whether formoterol passes into breast milk.

Small amounts of formoterol have been found in human milk in rats. The question of the use of Symbicort in women during lactation should be considered only if the expected benefit to the mother outweighs the possible risk to the child.

Fertility . There are no data on the potential effects of budesonide on fertility. In the course of studies of the effect of formoterol on the reproductive function of animals, a slightly reduced level of fertility was revealed in male rats with high systemic exposure.

The ability to influence the reaction rate when driving or working with other mechanisms. Symbicort does not affect or slightly affects the ability to drive vehicles and work with mechanisms.

Children. Symbicort is not recommended for use in children under 6 years of age. For use in children aged 6-11 years, there is a dosage form with a low dose (80 mcg / 4.5 mcg / dose).

Pharmacokinetic interactions. Plasma levels of budesonide may increase markedly with concomitant use with potent CYP 3A4 inhibitors (eg, ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin, telithromycin, nefazodone, and HIV protease inhibitors), so concomitant use of these drugs should be avoided.If this is not possible, the time interval between the use of the inhibitor and budesonide should be as long as possible (see SPECIAL INSTRUCTIONS).

A potent inhibitor of CYP 3A4 ketoconazole, which was used at a dose of 200 mg once a day, increased the concentration of oral budesonide in blood plasma (3 mg once) by an average of 6 times with their simultaneous use. When using ketoconazole 12 hours after budesonide, the concentration of budesonide increased by an average of 3 times, which indicates that the separate use of drugs with a certain period of time can reduce the frequency of increase in the concentration of budesonide in blood plasma.Limited data on this interaction with the use of high doses of inhaled budesonide show that in the case of simultaneous use of itraconazole at a dose of 200 mg 1 time per day and inhaled budesonide at a dose of 1000 mcg once, plasma levels of budesonide can increase significantly (on average by 4 times).

Pharmacodynamic interactions. β-adrenergic receptor blockers can weaken or suppress the effect of formoterol, therefore Symbicort should not be used together with β-adrenergic receptor blockers (including eye drops) unless there is a compelling reason for this.

With the simultaneous use of quinidine, disopyramide, procainamide, phenothiazines, antihistamines (terfenadine), as well as tricyclic antidepressants, the Q – Tc interval may be prolonged and the risk of ventricular arrhythmia may increase.

In addition, levodopa, levothyroxine, oxytocin and alcohol can interfere with the cardiac tolerance of β2-sympathomimetics.

The simultaneous use of MAO inhibitors, including drugs with similar properties, such as furazolidone and procarbazine, can cause hypersensitivity reactions.

Patients receiving halogenated hydrocarbon anesthesia have an increased risk of arrhythmia.

Concomitant use of other β-adrenergic or anticholinergic drugs may have a potentially additive bronchodilator effect.

Hypokalemia may increase the predisposition to arrhythmias in patients using digitalis glycosides (for more information on hypokalemia, see SPECIAL INSTRUCTIONS).

Interactions of budesonide and formoterol with other drugs used in asthma have not been noted.

Pediatric Populations . Drug interaction studies have only been conducted in adults.

MAO inhibitors and tricyclic antidepressants . Symbicort should be used with caution in patients taking MAO inhibitors or tricyclic antidepressants, as well as within 2 weeks after stopping treatment with such agents, since the effect of formoterol (Symbicort component) on the vascular system can be enhanced under the influence of these agents.

Diuretics . ECG changes and / or hypokalemia caused by the use of diuretics that do not belong to the potassium-sparing group (such as loop or thiazide diuretics) can suddenly increase under the influence of β-adrenergic receptor agonists, especially when the recommended dose of β-adrenergic receptor agonists is exceeded. Although the clinical significance of these effects remains unclear, caution is advised with the simultaneous use of Symbicort and diuretics that do not belong to the potassium-sparing group.

an overdose of formoterol is likely to result in effects typical of β2-adrenergic receptor agonists: tremors, headaches, palpitations. In rare cases, tachycardia, hyperglycemia, hypokalemia, prolongation of the interval Q-Tc , arrhythmias, nausea and vomiting have been reported. Supportive and symptomatic therapy may be indicated. The use of 90 μg for 3 hours in patients with acute bronchial obstruction was safe.

In acute overdose of budesonide, even in excessive doses, clinical manifestations are not expected.