Combivent Inhaler – Asthma Health Center

People who do not get sufficient relief from their asthma symptoms with a single bronchodilator that contains one fast-acting medication have the option of using a Combivent inhaler, which combines two medications in one inhaler. The Combivent inhaler, containing both albuterol and ipratropium, is primarily used by people with chronic obstructive pulmonary disease (COPD), but it may offer some benefit to people with more severe asthma, though it is not considered standard treatment for asthma.

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Combivent Inhaler: How it Works

“As the name implies, the Combivent inhaler is a combination of ingredients — a beta-2 agonist and another drug that acts on a different part on the pathways that control asthma,” explains Richard Castriotta, MD, professor of medicine and associate director of the Division of Pulmonary, Critical Care, and Sleep Medicine at the University of Texas Houston Medical School.

“In general, this group of drugs [is] not as powerful nor as quick-acting as the beta-2 agonists,” he says. “It doesn’t take effect within 10 minutes the way albuterol does. It may take an hour or two before you really have effects.”

Combivent Inhaler: Who May Benefit

Although some people can use their Combivent inhaler as a “rescue” inhaler, Dr. Castriotta says it might not act quickly enough. Instead, Combivent is considered an addition to the treatment regimen for people with severe or chronic asthma. “Combivent is usually prescribed as a maintenance drug, usually in people who have COPD,” he says. “People with COPD usually don’t have a good response to a bronchodilator” such as albuterol.

According to the National Heart, Lung, and Blood Institute, anticholinergic ipratropium, one of the key ingredients in this combination drug, might be an alternative for you if albuterol is not effective alone.

Combivent Inhaler: Warnings and Side Effects

Combivent should only be used as prescribed, basically for the relief of occasional symptoms. An overdose can be fatal. If you use the Combivent dosage your doctor prescribed and do not get relief, contact the doctor right away.

Be sure to discuss your use of a Combivent inhaler with your health care provider if you have any of the following conditions, as Combivent may make them worse:

Call your doctor if you have the following side effects while using Combivent:

• Chest pain
• Nausea
• Pain in your left arm
• Pounding heart
• Sweating
• Tight chest
• wheezing

New Inhalers: What You Should Know

Beginning in 2009, inhalers got a new look — a change mandated by law in an effort to protect the ozone layer. No longer can inhalers use chloroflourocarbons, known as CFCs, as the propellant that gets the medication into your lungs; instead, only hydroflouroalkane, or HFA, can be used going forward. That’s good for the environment because HFA does the same job at less cost to the ozone layer. But it means some changes in how you use your inhaler, too.

Talk to your doctor about using the new inhaler design, but know that you will need to make an extra effort to:

• Prime your inhaler when you use it.
• Inhale with more force to get your medication.
• Clean your mouthpiece more thoroughly.

Combivent may help relieve some of the symptoms of severe asthma. If you use, or are planning to use, a Combivent inhaler, make sure that you have thorough knowledge of how it works and that you and your doctor evaluate whether it truly benefits you.

Bronchodilator | COMBIVENT RESPIMAT® (ipratropium bromide/albuterol)

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Indication for Use and Important Safety Information

COMBIVENT RESPIMAT (ipratropium bromide and albuterol) is indicated for use in patients with chronic obstructive pulmonary disease (COPD) on a regular aerosol bronchodilator who continue to have evidence of bronchospasm (airway narrowing) and who require a second bronchodilator.

Important Safety Information

Do not use COMBIVENT RESPIMAT if you are allergic to any of the ingredients in COMBIVENT RESPIMAT or to atropine or other similar drugs.

COMBIVENT RESPIMAT can cause the narrowing of the airways to get worse (paradoxical bronchospasm) which may be life threatening. If this happens, stop taking COMBIVENT RESPIMAT at once and call your doctor or get emergency help.

COMBIVENT RESPIMAT can cause serious heart-related side effects, such as palpitations, chest pain, rapid heart rate, high blood pressure, tremor, or nervousness. Call your doctor if you experience any of these symptoms.

Avoid spraying COMBIVENT RESPIMAT into your eyes. COMBIVENT RESPIMAT may increase eye pressure which may cause or worsen some types of glaucoma. If you have sudden vision changes, eye pain or visual halos, stop taking COMBIVENT RESPIMAT and call your doctor right away.

COMBIVENT RESPIMAT may cause difficulty with urination.

Dizziness and blurred vision may occur with COMBIVENT RESPIMAT. Should you experience these symptoms, use caution when engaging in activities such as driving a car or operating appliances or other machines.

Do not use COMBIVENT RESPIMAT more often than your doctor has directed. Deaths have been reported with similar inhaled medicines in asthma patients who use the medicine too much. Seek medical attention if your treatment with COMBIVENT RESPIMAT becomes less effective for symptomatic relief, your symptoms become worse, and/or you need to use the product more frequently than usual.

Allergic reactions may occur, including itching, swelling of the face, lips, tongue, or throat (involving difficulty in breathing or swallowing), rash, hives, bronchospasm (airway narrowing), or anaphylaxis. Some of these may be serious. If you experience any of these symptoms, stop taking COMBIVENT RESPIMAT at once and call your doctor or get emergency help.

Tell your doctor about all your medical conditions, especially if you have narrow-angle glaucoma, prostate or urinary problems, a history of heart conditions (such as irregular heartbeat, high blood pressure), thyroid disorder, or diabetes. Also tell your doctor if you are pregnant or nursing. Tell your doctor about all medicines you are taking, especially heart medications or drugs to treat depression.

The most common side effects reported with use of COMBIVENT RESPIMAT include infection of the ears, nose, and throat, runny nose, cough, bronchitis, headache, and shortness of breath.

Click here for full Prescribing Information and Patient Instructions for Use.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

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Dosage, side effects, alternatives, and more

You may wonder how Combivent Respimat compares to other medications that are prescribed for similar uses. Here we look at how Combivent Respimat and Spiriva Respimat are alike and different.

Uses

The Food and Drug Administration (FDA) has approved both Combivent Respimat and Spiriva Respimat to treat chronic obstructive pulmonary disease (COPD) in adults. COPD is a group of lung diseases that includes chronic bronchitis and emphysema.

Before your doctor can prescribe Combivent Respimat, you must be using a bronchodilator in aerosol form. This is a type of medication that helps open up breathing passages in your lungs, and you inhale it. Also, you must still have bronchospasms (tightening of the muscles in your airways) and need a second bronchodilator.

Spiriva Respimatis also approved to treat asthma in adults and children ages 6 years and older.

Neither Combivent Respimat nor Spiriva Respimat is meant to be used as a rescue medication for COPD for immediate breathing relief.

Drug forms and administration

Combivent Respimat contains the drugs ipratropium and albuterol. Spiriva Respimat contains the drug tiotropium.

Both Combivent Respimat and Spiriva Respimat come in two pieces:

• inhaler device
• cartridge that contains the medication

Each inhalation (puff) of Combivent Respimat contains 20 mcg of ipratropium and 100 mcg of albuterol. There are 120 puffs in each cartridge.

Each puff of Spiriva Respimat contains 2.5 mcg of tiotropium to treat COPD. Cartridges come with 60 puffs in them.

For Combivent Respimat, the typical dose for COPD is one puff, four times a day. The maximum dose is one puff, six times a day.

For Spiriva Respimat, the typical dose for COPD is two puffs, once a day.

Side effects and risks

Combivent Respimat and Spiriva Respimat both contain medications in a similar drug class. Therefore, both medications can cause very similar side effects. Below are examples of these side effects.

More common side effects

These lists contain examples of more common side effects that can occur with Combivent Respimat, with Spiriva, or with both drugs (when taken individually).

• Can occur with Combivent Respimat:
  • few unique common side effects
• Can occur with Spiriva Respimat:
• Can occur with both Combivent Respimat and Spiriva Respimat:

Serious side effects

These lists contain examples of serious side effects that can occur with Combivent Respimat, with Spiriva, or with both drugs (when taken individually).

• Can occur with Combivent Respimat:
  • heart problems, such as a faster heart rate or chest pain
  • hypokalemia (low potassium levels)
• Can occur with Spiriva Respimat:
  • few unique serious side effects
• Can occur with both Combivent Respimat and Spiriva Respimat:

Effectiveness

Combivent Respimat and Spiriva Respimat have some different FDA-approved uses, but the two drugs are both used to treat COPD.

These drugs haven’t been directly compared in clinical studies, but studies have found both Combivent Respimat and Spiriva Respimat to be effective for treating COPD.

Costs

Combivent Respimat and Spiriva Respimat are both brand-name drugs. There are currently no generic forms of either drug.

However, the FDA has approved ipratropium and albuterol (the active ingredients in Combivent Respimat) as a generic drug used to treat COPD. This drug comes in a different form than Combivent Respimat. The generic drug comes as a solution (liquid mixture) that’s used in a device called a nebulizer. This nebulizer turns the drug into a mist that you inhale through a mask or mouthpiece.

According to estimates on GoodRx.com, Combivent Respimat and Spiriva generally cost about the same. The generic drug of ipratropium and albuterol will typically be less expensive than either Combivent Respimat or Spiriva. The actual price you’ll pay for these drugs depends on your insurance plan, your location, and the pharmacy you use.

Combivent Respimat Inhalation: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing

Read the Patient Information Leaflet if available from your pharmacist before you start using this product and each time you get a refill. Learn how to use this inhaler properly. If you have any questions, ask your doctor or pharmacist.

Follow the instructions for priming the inhaler if you are using it for the first time or if you have not used it for more than 3 days or for more than 21 days. When priming the inhaler, make sure to spray away from the face so that you do not get the medication into your eyes.

Inhale this medication by mouth as directed by your doctor, usually 4 times daily. Your doctor may also direct you to use this medication as needed for wheezing and shortness of breath. Follow your doctor’s instructions carefully. However, the manufacturer recommends that you do not use more than 6 inhalations in a 24-hour period. Doing so may increase the risk of serious side effects.

The dosage is based on your medical condition and response to treatment.

Avoid getting this medication into your eyes. It may cause eye pain/irritation, temporary blurred vision, and other vision changes. Therefore, when using the inhaler, put your lips tightly around the mouthpiece.

Rinse your mouth after using the inhaler to prevent dry mouth and throat irritation.

If you are using other inhalers at the same time, wait at least 1 minute between the use of each medication.

Use this medication regularly to get the most benefit from it. This medication works best if used at evenly spaced intervals. To help you remember, use it at the same times each day. Do not increase your dose, use this medication more often, or stop using it without first consulting your doctor.

Clean the mouthpiece of the inhaler at least once a week as directed.

Learn which of your inhalers you should use every day and which you should use if your breathing suddenly worsens (quick-relief drugs). Ask your doctor ahead of time what you should do if you have new or worsening cough or shortness of breath, wheezing, increased sputum, waking up at night with trouble breathing, if you use your quick-relief inhaler more often, or if your quick-relief inhaler does not seem to be working well. Learn when you can treat sudden breathing problems by yourself and when you must get medical help right away.

Tell your doctor if your symptoms do not improve or if they worsen.

Phase Out of Combivent Inhalation Aerosol – Questions and Answers

1. Why are Combivent Inhalation Aerosol inhalers being phased out?

Combivent Inhalation Aerosol inhalers are being phased out because they contain chlorofluorocarbons or CFCs, which are substances that harm the environment because they decrease the protective ozone layer above the Earth. 

Under the Montreal Protocol on Substances that Deplete the Ozone Layer, the United States and other participating countries promised to make it illegal to make or sell substances that decrease the ozone layer, including CFCs, after certain dates.

Combivent Inhalation Aerosol uses CFCs as propellants (spray) to move the medicine out of the inhaler so patients can breathe the medicine into their lungs.

2. When will Combivent Inhalation Aerosol inhalers be gone?

Combivent Inhalation Aerosol inhalers cannot be made or sold after December 31, 2013. However, the manufacturer of the product, Boehringer Ingelheim Pharmaceuticals, reports that Combivent Inhalation Aerosol will be discontinued in July 2013. 

3. Why is Combivent Inhalation Aerosol being removed from the market early?

The manufacturer, Boehringer Ingelheim Pharmaceuticals, developed an alternative product, Combivent Respimat, and is transitioning patients early to ensure that the phase out is completed ahead of the December 31, 2013 date. Combivent Respimat does not contain CFCs.

4. What is Combivent Respimat?

Combivent Respimat (ipratropium bromide and albuterol sulfate) Inhalation Spray is a medication approved for patients with chronic obstructive pulmonary disease (COPD) who are on a regular aerosol bronchodilator but continue to have bronchospasms and need a second bronchodilator. Combivent Respimat contains two different types of medicines that open airways in the lungs to help patients with COPD breathe better. These two medicines are the same medicines contained in Combivent Inhalation Aerosol. Combivent Respimat is a suitable alternative for patients who are currently using Combivent Inhalation Aerosol.

5. What should I do if I use a Combivent Inhalation Aerosol inhaler?

If you use a Combivent Inhalation Aerosol inhaler, talk with your health care professional about switching to an inhaler that does not contain CFCs because Combivent Inhalation Aerosol inhalers will be discontinued by the manufacturer in July 2013. If you are still using a Combivent Inhalation Aerosol inhaler on December 31, 2013, the last day the inhaler can be sold under the Montreal Protocol, you may continue to use the inhaler as long it has not expired. Check the expiration date, which can be found on the product and its packaging.

6. What other inhalers can I use for my COPD?

There are many other inhalers available in the United States that do not contain CFCs. Talk to your health care professional to decide which choice is right for you. To see some of the FDA-approved inhalers for asthma and COPD, visit the web page: Drug Treatments for Asthma and Chronic Obstructive Pulmonary Disease that Do Not Use Chlorofluorocarbons.

7. How can I find out more about the phase-out of CFC inhalers?

More information about the phase-out of CFC inhalers can be found on these FDA webpages:

Related Information

• Content current as of:

  10/20/2015

Ipratropium Bromide and Albuterol Sulfate

Brief Summary

Combivent (ipratropium bromide and albuterol sulfate) is a combination of ipratropium bromide (as the monohydrate) and albuterol sulfate. These medications are used as rescued inhalers.

Proven Uses

COMBIVENT Inhalation Aerosol is indicated for use in patients with chronic obstructive pulmonary disease (COPD) on a regular aerosol bronchodilator who continue to have evidence of bronchospasm and who require a second bronchodilator.

COMBIVENT Inhalation Aerosol was significantly more effective than ipratropium bromide or albuterol sulfate administered alone.

Side Effects

Adverse reactions, reported in less than two percent of the patients in the COMBIVENT Inhalation Aerosol treatment group include edema, fatigue, hypertension, dizziness, nervousness, paresthesia, tremor, dysphonia, insomnia, diarrhea, dry mouth, dyspepsia, vomiting, arrhythmia, palpitation, tachycardia, arthralgia, angina, increased sputum, taste perversion, and urinary tract infection/dysuria.

Allergic-type reactions such as skin rash, angioedema of tongue, lips and face, urticaria (including giant urticaria), laryngospasm and anaphylactic reaction have been reported with Combivent.

Other common side effects may include headache, pain, influenza, nausea, rhinitis, sinusitis and coughing.

Precautions

Use COMBIVENT Inhalation Aerosol exactly as prescribed by your doctor.

Do not change your dose or how often you use COMBIVENT Inhalation Aerosol without talking with your doctor.

NOTE:  COMBIVENT Contains trichloromonofluoromethane (CFC-11), dichlorodifluoromethane (CFC-12) and dichlorotetrafluoroethane (CFC-114), substances which harm public health and the environment by destroying ozone in the upper atmosphere.

Since Combivent contains CFC it may not be available after December 2008.

Adapted from Source: http://www.fda.gov/cder/foi/label/2008/020291s023lbl.pdf

Albuterol and Ipratropium Oral Inhalation: MedlinePlus Drug Information

The combination of albuterol and ipratropium comes as a solution (liquid) to inhale by mouth using a nebulizer (machine that turns medication into a mist that can be inhaled) and as a spray to inhale by mouth using an inhaler. It is usually inhaled four times a day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use albuterol and ipratropium exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

Your doctor may tell you to use additional doses of albuterol and ipratropium inhalation if you experience symptoms such as wheezing, difficulty breathing, or chest tightness. Follow these directions carefully, and do not use extra doses of medication unless your doctor tells you that you should. Do not use more than 2 extra doses of the nebulizer solution per day. Do not use the inhalation spray more than six times in 24 hours.

Call your doctor if your symptoms worsen, if you feel that albuterol and ipratropium inhalation no longer controls your symptoms, or if you find that you need to use extra doses of the medication more often.

If you are using the inhaler, your medication will come in cartridges. Each cartridge of albuterol and ipratropium inhalation spray is designed to provide 120 inhalations. This is enough medication to last one month if you use one inhalation four times a day. After you use all 120 doses, the inhaler will lock and will not release any more medication, There is a dose indicator on the side of the inhaler that keeps track of how much medication is left in the cartridge. Check the dose indicator from time to time to see how much medication is left. When the pointer on the dose indicator enters the red area, the cartridge contains enough medication for 7 days and it is time to refill your prescription so that you will not run out of medication.

Be careful not to get albuterol and ipratropium inhalation into your eyes. If you get albuterol and ipratropium in your eyes, you may develop narrow angle glaucoma (a serious eye condition that may cause loss of vision). If you already have narrow angle glaucoma, your condition may worsen. You may experience widened pupils (black circles in the center of the eyes), eye pain or redness, blurred vision, and vision changes such as seeing halos around lights, or seeing unusual colors Call your doctor if you get albuterol and ipratropium into your eyes or if you develop these symptoms.

The inhaler that comes with albuterol and ipratropium spray is designed for use only with a cartridge of albuterol and ipratropium. Never use it to inhale any other medication, and do not use any other inhaler to inhale the medication in a cartridge of albuterol and ipratropium.

Before you use albuterol and ipratropium inhalation for the first time, read the written instructions that come with the inhaler or nebulizer. Ask your doctor, pharmacist, or respiratory therapist to show you how to use it. Practice using the inhaler or nebulizer while he or she watches.

To prepare the inhaler for use, follow these steps:

1. Put the inhaler together before you use it for the first time. To start, take the inhaler out of the box, and keep the orange cap closed. Press the safety catch and pull off the clear base of the inhaler. Be careful not to touch the piercing element inside of the base
2. The inhaler must be discarded three months after you put it together. Write this date on the label of the inhaler so you will not forget when you need to discard your inhaler.
3. Take the cartridge out of the box and insert the narrow end into the inhaler. You can press the inhaler against a hard surface to be sure it is inserted correctly. Replace the clear plastic base on the inhaler.
4. Hold the inhaler upright with the orange cap closed. Turn the clear base in the direction of the white arrows until it clicks.
5. Flip the orange cap so that it is fully open. Point the inhaler toward the ground.
6. Press the dose release button. Close the orange cap.
7. Repeat steps 4-6 until you see a spray coming out of the inhaler. Then repeat these steps three more times.
8. The inhaler is now primed and ready for use. You will not need to prime your inhaler again unless you do not use it for longer than 3 days. If you do not use your inhaler for more than 3 days, you will need to release one spray toward the ground before you start to use it again. If you do not use your inhaler for more than 21 days, you will need to follow steps 4-7 to prime the inhaler again.

To inhale the spray using the inhaler, follow these steps:

1. Hold the inhaler upright with the orange cap closed. Turn the clear base in the direction of the white arrows until it clicks.
2. Open the orange cap.
3. Breathe out slowly and completely.
4. Place the mouthpiece in your mouth and close your lips around it. Be careful not to cover the air vents with your lips.
5. Point the inhaler toward the back of your throat and breathe in slowly and deeply.
6. While you are breathing in, press the dose release button. Continue to breathe in as the spray is released into your mouth.
7. Hold your breath for 10 seconds or as long as you comfortably can.
8. Take the inhaler out of your mouth and close the orange cap. Keep the cap closed until you are ready to use the inhaler again.

To inhale the solution using a nebulizer, follow these steps:

1. Remove one vial of medication from the foil pouch. Put the rest of the vials back into the pouch until you are ready to use them.
2. Twist off the top of the vial and squeeze all of the liquid into the reservoir of the nebulizer.
3. Connect the nebulizer reservoir to the mouthpiece or face mask.
4. Connect the nebulizer reservoir to the compressor.
5. Put the mouthpiece in your mouth or put on the face mask. Sit in a comfortable, upright position and turn on the compressor.
6. Breathe in calmly, deeply, and evenly through your mouth for about 5 to 15 minutes until mist stops forming in the nebulizer chamber.

Clean your inhaler or nebulizer regularly. Follow the manufacturer’s directions carefully and ask your doctor or pharmacist if you have any questions about cleaning your inhaler or nebulizer.

Combined inhalation drugs – a new approach to the treatment of bronchial asthma | Avdeev S.N.

In it has been proven that the most effective drugs for the control of bronchial asthma (BA) are inhaled glucocorticosteroids (ICS) . ICS at recommended doses is well tolerated and considered safe. ICS are prescribed when the need for β ₂ β-agonists to control symptoms in a patient with asthma is more than 3 times a week (Barnes & Godfrey, 1988).According to the recommendations of the international consensus documents (GINA), ICS is indicated for all patients with persistent asthma, including those with a mild course of the disease (NIH / NHLBI, 1998). The arguments for early prescription of ICS in AD are: 1) inflammation of the respiratory tract mucosa is present even at the earliest stages of AD; 2) ICS are the most effective anti-inflammatory drugs for asthma in comparison with other known drugs; 3) cancellation of ICS in patients with mild BA can lead to an exacerbation of the disease; 4) ICS prevent the progressive decrease in pulmonary functional parameters that occurs in BA patients over time (O’Byrne, 1999).

Often, when BA is not controlled by the prescribed doses of ICS, the question arises: should the dose of ICS be increased or another drug should be added? From the point of view of ensuring a safe profile of the applied therapy, the selection of the lowest possible effective doses of ICS in combination with another drug is the most reasonable approach to control asthma.

Prerequisites for the use of combination drugs

Prolonged b ₂ β-agonists are currently considered the most effective drugs for combination with ICS (Barnes P.J., 2001). The scientific rationale for such a combination stems from the complementary effects of ICS and b ₂ agonists. Steroids increase the expression of the b ₂ receptor gene and reduce the potential for the development of receptor desensitization, while b ₂ agonists activate inactive glucocorticoid receptors, making them more sensitive for steroid-dependent activation (Roth et al., 2001) … In addition, the inhibitory effect of b ₂ -agonists on stimulators of bronchial smooth muscle contraction, on plasma sweating into the airway lumen, on the influx of inflammatory cells during an exacerbation of asthma, as well as an increase in the deposition of ICS in the airways due to their expansion after inhalation of b ₂ -agonists (Pauwels et al., 1997).

Other, even more weighty arguments in favor of the combined use of ICS with prolonged b ₂ -agonists are the positive results of clinical trials that have proven the greater effectiveness of the combination of drugs in comparison with increased doses of ICS. Combinations of beclomethasone and salmeterol, fluticasone and salmeterol (Shrewsbury et al., 2000), budesonide and formoterol (Pauwels et al., 1997).

In a large multicenter FACET study, which included 852 BA patients, for 1 year, the efficacy of a combination of formoterol and budesonide and double doses of budesonide was compared. All patients were divided into 4 groups: 1) budesonide at a dose of 400 μg / day; 2) budesonide at a dose of 400 mcg / day plus formoterol 24 mcg / day; 3) budesonide at a dose of 800 mcg / day; 4) budesonide 800 mcg / day plus formoterol 24 mcg / day (Pauwels et al., 1997). In patients taking the combination of drugs, there was a more significant improvement in day and night symptoms, an increase in forced expiratory volume in 1 second (FEV ₁ ) and peak expiratory flow rate (PEF) (Fig.one). The number of severe and mild asthma exacerbations was reduced by 49 and 37% while taking a high dose of budesonide and by 26% and 40%, while taking low doses of budesonide and formoterol, respectively; however, the greatest decrease in exacerbations was observed in patients taking high doses of budesonide and formoterol (by 63 and 62%). Thus, the addition of formoterol to both high and low doses of budesonide made it possible to provide better control over the course of asthma as compared to monotherapy with budesonide. The FACET study also showed that combination therapy leads to improved quality of life for patients (Juniper et al., 1999).

Fig. 1. Dynamics of FEV1 under various treatment regimens

Despite the encouraging results of clinical studies, there was a concern that the combination of low doses of ICS with prolonged b ₂ -agonists has a smaller effect on inflammation compared to high doses of ICS, and better functional parameters are achieved due to additional bronchodilation caused by b ₂ -agonists. Direct evidence of the lack of “masking” of airway inflammation in combination therapy has recently been confirmed by morphological studies.In a randomized controlled trial, Kips et al. a comparison was made of the effect of the two therapy regimens on inflammatory markers of induced sputum in 60 patients with moderate BA. Patients received either budesonide at a dose of 800 mcg per day or budesonide 200 mcg per day plus formoterol 24 mg per day for 1 year. Both therapies effectively reduced eosinophil counts, EG2 (+) cells, and eosinophilic cationic protein levels; the groups of patients also did not differ significantly in the frequency of BA exacerbations.

The high efficiency of combination therapy in AD with b ₂ long-acting agonists with ICS served as a prerequisite for the creation of combined drugs, an example of which is Symbicort Turbuhaler (budesonide 160 mcg + formoterol 4.5 mcg).

Symbicort Turbuhaler

One of the main advantages of Symbicort Turbuhaler is the possibility of flexible adaptation of the dose of the drug (the number of doses and the number of doses of the drug), depending on the severity of symptoms and the course of asthma.The initial dose to achieve BA control is two inhalations (160 / 4.5 mcg) twice daily (Shaw & Jackson, 2001). After improvement of asthma symptoms, it is possible to switch to one inhalation twice a day using the same inhaler or even to a single dose of one dose of the drug. If symptoms worsen, for example, during an acute respiratory viral infection, the doses of the drug can be increased again without the need to switch to a new drug.

A distinctive feature of the combined drug Symbicort Turbuhaler is the high rate of development of the therapeutic effect, which is undoubtedly associated with the properties of formoterol (onset of action in 1-3 minutes).In addition, the properties of budesonide (good solubility in the aqueous phase) also provide a quick effect: the effect on pulmonary functional parameters is manifested within 1 hour, and on inflammatory markers within 3-5 hours (Le Merre, 1997).

In a double-blind crossover study, Palmquist et al. compared the rapidity of the onset of the bronchodilating effect of one and two inhalations of Symbicort Turbuhaler 160 / 4.5 μg and one inhalation of Seretide Discus 50/250 μg in 13 BA patients during the first 3 hours after inhalation.The advantage of both doses of Symbicort was noticeable already 3 minutes after inhalation (FEV ₁ : 2.74 L, 2.75 L and 2.56 L, respectively, p <0.001) and persisted for 3 hours.

Aerosol delivery device

The effectiveness of inhalation therapy depends not only on the chemical structure of the drug, but also on the device for delivering the aerosol to the respiratory tract. An ideal delivery device should ensure the deposition of a large fraction of the drug in the lungs, be simple enough to use, reliable and affordable for use at any age and in severe forms of the disease.The delivery of a drug to the respiratory tract depends on many factors, the most important of which is the particle size of the drug aerosol. Particles up to 5 microns in size – respirable particles are of interest for inhalation therapy. Turbuhaler powder inhaler is used as a delivery system for the budesonide / formoterol combination. This delivery system does not use a drug carrier, is easy to handle, and has two new additions – a dose counter and a more convenient mouthpiece.

Turbuhaler is one of the most effective forms of powder inhalers, providing the highest drug deposition in the lungs – up to 32% of the metered dose (Edsbacker, 1999). However, these results were obtained with inhalation of budesonide, while the fraction of the drug delivered to the respiratory tract depends more on the drug / delivery device combination than on the device itself. When prescribing doses of inhaled drugs, it is very important to take into account such an indicator as the variability of the deposition of drugs, it should be minimal.

Studies carried out in vitro demonstrated that when using the Turbuhaler inhaler, the respirable dose of the budesonide / formoterol combination did not go beyond the range of acceptable dose variability (Lindblad et al., 2000). In another bench study comparing the properties of the inhalation systems Symbicort Turbuhaler and Seretid Discus, it was found that the delivery of respirable particles with the Symbicort Turbuhaler system reaches 50% compared to 20% for the Seretid Discus system (Granlund et al., 2000).

Comparative efficiency

A recently published 12-week, double-blind, randomized controlled trial compared the efficacy of Symbicort Turbuhaler with a combination of separate budesonide (Pulmicort Turbuhaler) and formoterol (Oxis Turbuhaler) (Zetterstrom et al., 2001). The study included 362 patients with moderate BA (average FEV ₁ 73.8%), in whom the course of the disease was not controlled by ICS monotherapy.Patients were randomized into 3 treatment groups: 1) Symbicort 160 / 4.5 mcg twice a day; 2) Pulmicort 200 mcg plus Oxis twice a day; 3) Pulmicort 200 mcg twice a day. In the therapy groups Symbicort and the combination Pulmicort plus Oxis, there was a significant improvement in the morning PSV value compared with the Pulmicort monotherapy group: 35.7 l / min, 32.0 l / min and 0.20 l / min, respectively (p <0.001) ( fig. 2). In the first two groups, there was also a significant improvement in evening PSV parameters, a decrease in the number of inhalations of b ₂ short-acting agonists.Therapy with Symbicort and the combination Pulmicort plus Oxis was accompanied by an increase in days free from disease symptoms by an average of 15% compared with Pulmicort. The risk of developing mild exacerbations of asthma was also significantly lower in the first two groups (p <0.01), and the time during which no exacerbations of asthma were observed in patients significantly lengthened in the groups of combination therapy (Fig. 3). It should be noted that the improvement of PSV parameters and the achievement of BA control were achieved faster with Symbicort therapy compared to the combination Pulmicort plus Oxis, which is an argument in favor of the greater efficacy of the combined drug.

Fig. 2. Dynamics of PSV under various treatment regimens

Fig. 3. The number of patients without asthma exacerbation with different treatment regimens

Possibility of using once a day

Despite the proven effectiveness of ICS in AD, compliance is a significant problem, i.e. adherence of patients to follow prescribed therapy. Only about 40% of all asthma patients are conscientious in fulfilling their prescriptions (Schmier & Leidy, 1998).The reasons for poor compliance to therapy are quite diverse, one of them is an overly complex medication regimen, therefore, reducing the number of doses of the drug can improve compliance, and, consequently, the effectiveness of ICS therapy. Several studies have been conducted comparing the effectiveness of taking a daily dose of ICS once a day or in 2-4 doses; most of these works are devoted to budesonide and its unique ability to bind with fatty acids inside the cell (Edsbacker, 1999). Conjugated budesonide does not bind to receptors, but remains inside the cell.Over time, under the action of intracellular lipases, budesonide is slowly released and regains the ability to interact with receptors, thus providing a prolonged anti-inflammatory effect. The effectiveness of a single dose of budesonide has been shown in patients with mild to moderate asthma, both in those who have already taken ICS and those who have not previously taken ICS (Shaw & Jackson, 1998; Campbell, 1999).

Despite the proven efficacy of ICS in AD, compliance is a significant problem, i.e.e. Patient adherence to follow prescribed therapy. Only about 40% of all asthma patients are conscientious in fulfilling their prescriptions (Schmier & Leidy, 1998). The reasons for poor compliance to therapy are quite diverse, one of them is an overly complex medication regimen, therefore, reducing the number of doses of the drug can improve compliance, and, consequently, the effectiveness of ICS therapy. Several studies have been conducted comparing the effectiveness of taking a daily dose of ICS once a day or in 2-4 doses; most of these works are devoted to budesonide and its unique ability to bind with fatty acids inside the cell (Edsbacker, 1999).Conjugated budesonide does not bind to receptors, but remains inside the cell. Over time, under the action of intracellular lipases, budesonide is slowly released and regains the ability to interact with receptors, thus providing a prolonged anti-inflammatory effect. The effectiveness of a single dose of budesonide has been shown in patients with mild to moderate asthma, both in those who have already taken ICS and those who have not previously taken ICS (Shaw & Jackson, 1998; Campbell, 1999).

Considering the long-term effect of formoterol, the question arises about the possibility of a single use of a fixed combination of budesonide / formoterol in BA patients.The use of just one inhaler and only once a day has a very high chance of increasing patients’ compliance with therapy, and, consequently, its effectiveness.

At the 2001 Annual Congress of the European Respiratory Society in Berlin, the first results of studies on the single use of Symbicort in patients with asthma were presented. In a double-blind, randomized, controlled study by Buhl et al., Which included 523 patients with mild and moderate BA, for 12 weeks, a comparison was made between Symbicort 160 / 4.5 μg once (evening) and 160 / 4.5 μg Symbicort twice daily therapy. and budesonide 200 μg once (Buhl et al., 2001). A single use of Symbicort in its effectiveness was not inferior to a double dose, and surpassed therapy with budesonide in such indicators as the increase in PSV, FEV ₁ , taking short-acting bronchodilators (p <0.05). In addition, a single dose of Symbicort reduced the risk of developing mild exacerbations of asthma by 38% compared with budesonide (p = 0.002), increased the number of days free from asthma symptoms (p = 0.01). In another study of a similar design, which included 616 patients with mild to moderate asthma, approximately the same results were obtained: a single use of Symbicort compared with budesonide more effectively controlled such indicators as PSV and FEV ₁ , the number of days free from AD symptoms and the need for short-acting bronchodilators (Kuna et al., 2001). Thus, based on the results of these studies, it is possible to draw conclusions about the good efficacy of a single use of Symbicort in mild and moderate asthma.

Impact on quality of life

Comparison of the effect of Symbicort and Pulmicort plus Oxis on quality of life was studied by Rosental et al. (2001), which included 586 BA patients. The patients received either Symbicort 160 / 4.5 μg twice a day for 6 months, or a combination of Pulmicort 200 μg plus Oxis 4.5 μg twice a day.The quality of life, assessed by the Mini Asthma Quality of Life Questionnaire scale, increased in both groups of patients (from 5.32 to 5.87 and from 5.42 to 5.80 points, respectively), BA control, assessed using the Asthma Control Questionnaire also improved (from 1.58 to 1.08 and from 1.46 to 1.00 points, respectively). Thus, both methods of using combined drugs have approximately the same effect on the quality of life and asthma control.

Cost-effectiveness ratio

Studies to date show that the use of combination products is more cost effective than a combination of separate products.In a study by Rosental et al. an analysis of direct and indirect costs was carried out for two regimens of therapy with combination drugs. Direct costs (cost of drugs, doctor’s consultation, hospitalization, etc.) were significantly lower in the group of patients taking Symbicort, compared with patients taking the combination Pulmicort plus Oxis: by about $ 91 per patient for 6 months (p = 0.003 ). Indirect costs (disability) were also lower in patients taking Symbicort, by an average of $ 119.for 1 patient for 6 months.

Security Profile

The safety and tolerability of the constituent components of Symbicort Turbuhaler – budesonide and formoterol – is based on the experience gained during the use of these drugs for 9 billion man-days for budesonide and 345 million man-days for formoterol. In all clinical trials devoted to Symbicort, the number of side effects while taking the drug was insignificant, and cases of patients dropping out of the study due to complications developed were extremely rare.

A placebo-controlled double-blind study Ankerst et al., 2001 was devoted to the study of cardiovascular effects when taking high doses of Symbicort. In the course of this study, patients received two inhalations of Symbicort 160 / 4.5 μg daily for 4-8 weeks, at the same time, on one of the days, the patient was prescribed 10 inhalations of Symbicort 160 / 4.5 mcg, either placebo or Oxis 4.5 mcg. As it turned out, even the appointment of high doses of Symbicort did not lead to significant changes in blood pressure, QT interval, potassium, glucose and lactate levels in the blood.There was only a slight increase in heart rate (5.4 beats per minute compared with placebo). Thus, even if the patient significantly increases the dose of the combined inhaler when BA symptoms worsen, this will not entail serious side effects.

Literature:

1. Barnes PJ, Godfrey S. Asthma therapy. Martin Dunitz Ltd, London, 1998: pp. 1- 150.

2. National Heart, Lung and Blood Institute, National institutes of Health, Word Health Organization.Global Initiative for Asthma. Bethesda: NIH / NHLBI, 1998; publication number 96-3659B

3. O’Byrne PM. Inhaled corticosteroid therapy in newly detected mild asthma. Drugs 1999; 58 (Suppl. 4): 17- 24

4. Barnes PJ. Clinical outcome of adding long-acting beta-agonists to inhaled corticosteroids. Respir Med 2001 Aug; 95 Suppl B: S12-6

5. Roth M., Rudiger J. J., Bihl M. P., Leufgen H., Cornelius B. C., Gencay M., Soler M., Perruchoud A. P., Tamm M.The b2-agonist formoterol activates the glucocorticoid receptor in vivo. Eur Respir J 2000; 18 (Suppl 31): 437s- 438s.

6. Pauwels RA, Lofdahl CG, Postma DS, et al. Effect of inhaled formoterol and budesonide on exacerbations of asthma. N Engl J Med 1997; 337: 1405-11

7. Shrewsbury S, Pyke S, Britton M. Meta-analysis of increased dose of inhaled steroid or addiction of salmeterol in symptomatic asthma (MIASMA). Brit Med J 2000; 320: 1368-73.

8.Juniper EF, Svensson K, O’Byrne PM, Barnes PJ, Bauer C-A, Lofdahl C-GA ,. Postma DS, Pauwels RA, Tattersfield AE, Ullman A. Asthma quality of life during 1 year of treatment with budesonide with or without formoterol. Eur Respir J 1999; 14: 1038-1043.

9. Kips JC, O’Connor BJ, Inman MD, Svensson K, Pauwels RA, O’Byrne PM. A long-term study of the antiinflammatory effect of low-dose budesonide plus formoterol versus high-dose budesonide in asthma. Am J Respir Crit Care Med 2000 Mar; 161 (3 Pt 1): 996-1001

10.Shaw M, Jackson W. Symbicort. Product Monograph. The single inhaler for asthma. Clinical Vision Ltd and AstraZeneka, 2001: pp. 1-52.

11. Palmqvist M, Arvidsson P, Beckman O, Peterson S, Lotvall J. Onset of bronchodilation of budesonide / formoterol vs. salmeterol / fluticasone in single inhalers. Pulm Pharmacol Ther 2001; 14 (1): 29-34

12. Edsbacker S. Pharmacological factors that influence the choice of inhaled corticosteroids. Drugs 1999; 58 (Suppl. 4): 7- 16.

13.Lindblad T., Granlund K. M., Rollwage U., Steckel H., Trofast E. Characteristics of a dry powder inhaler containing both budesonide and formoterol. Eur Respir J 2000; 18 (Suppl 31): 455s

14. Granlund K. M., Asking L., Lindblad T., Rollwage U., Steckel H. An in-vitro comparison of budesonide / formoterol and fluticasone / salmeterol in dry powder inhalers. Eur Respir J 2000; 18 (Suppl 31): 455s

15. Zetterstrom O, Buhl R, Mellem H, Perpina M, Hedman J, O’Neill S, Ekstrom T.Improved asthma control with budesonide / formoterol in a single inhaler, compared with with budesonide alone. Eur Respir J 2001 Aug; 18 (2): 262-8

16. Schmier JK, Leidy NK. The complexity of treatment adherence in adults with asthma challenges and opportunities. J Asthma 1998; 35: 455-72.

17. Shaw M, Jackson W. Pulmicort Turbuhaler once daily. Clinical Vision Ltd and Astra Drago AB, 1998: pp. 1-43.

18. Campbell LM. Once-daily inhaled corticosteroids in mild to moderate asthma.Drugs 1999; 58 (Suppl. 4): 25- 33.

19. Buhl R., Creemers J.P.H.M., Vondra V., Martelli N.A. Once-daily budesonide / formoterol via a single inhaler is effective in mild-to-moderate persistent asthma. Eur Respir J 2001; 18 (Suppl 33): 21s

20. Buhl R., Creemers J.P.H.M., Vondra V., Martelli N.A. Improved and maintained asthma control with once-daily budesonide / formoterol single inhaler therapy in mild-to-moderate persistent asthma. Eur Respir J 2001; 18 (Suppl 33): 21s

21.Kuna P., Chuchalin A., Ringdal N., De la Padilla EA, Black P., Lindqvist A., Nihlen U., Vogelmeier C. Low-dose single-inhaler budesonide / formoterol administered once daily is effective in mild-persistent asthma. Eur Respir J 2001; 18 (Suppl 33): 158s

22. Ankerst J., Persson G., Weibull E. A high dose of budesonide / formoterol in a single inhaler was well tolerated by asthmatic patients. Eur Respir J 2000; 18 (Suppl 31): 33s

23. Rosenhall L., Stahl E., Heinig J.H., Lindqvist A., Leegard J., Bergqvist P.B.F. Health – related quality of life and asthma control in patients treated with budesonide and formoterol in a single inhaler. Eur Respir J 2001; 18 (Suppl 33): 46s

24. Rosenhall L., Ericsson K., Borg S., Andersson F. Healthcare costs are reduced when asthma is treated with budesonide and formoterol in a single inhaler compared with the same medication via separate inhalers. Eur Respir J 2001; 18 (Suppl 33): 54s

Budesonide + formoterol –

Symbicort Turbuhaler (trade name)

(AstraZeneca)

.

Treatment of bronchial asthma

Bronchial asthma is a chronic infectious and allergic disease of the bronchi, manifested by inflammation of the bronchi and the appearance of attacks of shortness of breath.

The main mechanism of bronchial asthma is the narrowing of the bronchi caused by spasm of the muscles of the bronchi, edema of the bronchial mucosa and the accumulation of thick sputum. In addition, the disease has a pronounced connection with allergies and attacks are provoked by contact with various allergens – plant pollen, dust, chemical reagents, etc.Also, bronchial asthma is considered a psychosomatic disease, there is a link between stress and exacerbation of attacks.

All of the above determines the main directions in the treatment of bronchial asthma.

To quickly eliminate an attack, inhalers are used: salbutamol, fenoterol (berotek), terbutaline. Intravenous administration of aminophylline is sometimes used.

Treatment of asthma (and not just relief of an attack) requires an integrated approach, combining medication and non-medication methods.

First (and this is not a prescription for drugs), lifestyle changes. This is a hypoallergenic diet and a hypoallergenic lifestyle. This means reducing (ideally eliminating) contact with allergens: inhaled, ingested with food, and getting on the skin. Sometimes you have to change your place of residence for this. Sanitation (cleansing) of foci of chronic diseases (sinuses, teeth, tonsils, nasopharynx and oropharynx) is also desirable. Psychotherapy is recommended to adapt (increase resistance) to stress loads.

Medicines should be selected by a pulmonologist after examination and examinations (peakfluometry, spirometry, radiography, pulse oximetry). Medicines differ in their mechanism of action and indications for prescription:

– anti-allergic,

– bronchospasmolytics,

– non-hormonal inhalation drugs,

– adrenergic agonists and antileukotriene agents,

– cromones,

– anticholinergics,

– expectorants,

– inhalation hormonal agents,

– glucocorticosteroids,

– sodium bicarbonate,

– combination preparations.

Thus, treatment for bronchial asthma is the selection of the most effective drugs for relieving seizures and preventing seizures.

A stepwise approach is used for treatment, depending on the severity of the condition. If the condition worsens, a transition to a higher level of treatment. If the condition improves, the opposite is true. To comply with the stepwise approach, constant monitoring of the patient’s condition is necessary, which means regular meetings between the patient and the pulmonologist.

In the treatment of bronchial asthma, physiotherapy is actively used: aerosol therapy (through an ultrasonic nebulizer), aeroionotherapy, magnetotherapy, laser therapy, electrotherapy, phonophoresis, massage, hydrotherapy, hardening, electrosleep, halotherapy (salt cave), sunbathing.

For prevention and improvement of vitality spa treatment is indicated. For asthma treatment to be of the greatest benefit, it is necessary to carefully approach the choice of a resort – this will help not only improve your health, but also get a good experience.

There are many factors to consider, one of which is acclimatization. When moving to other climatic conditions, the human body goes through the so-called adaptation period. During the adaptation time, there is a deterioration in well-being, and the sharper the climate is, the worse a person tolerates the move. Therefore, we recommend choosing a sanatorium located in a place where the climate differs little from your usual one.

For patients with bronchial asthma, it is best to visit the resort at a time when ragweed and other plants are not blooming, which can cause a severe allergic reaction.Plant pollen most often provokes an exacerbation of the disease. It is better to prefer boarding houses located in high-mountainous regions or in the territory of coniferous forests.

In the event of a holiday in a sanatorium zone in another part of the country or abroad, the holidaymaker expects a change in the usual hour mode. It also has a negative impact on health, especially when traveling by plane. In a short period, the body does not have time to rebuild. Long trips are best done by train, including with children.

If you have doubts about the correctness of using a particular method or medicine, consult your doctor (pulmonologist, therapist).

Make an appointment with a pulmonologist by phone: (8332) 22-03-03

Modern combined inhalation drugs for the treatment of bronchial asthma | Lines

1. Coutts J.A.P., Gibson N.A., Paton J.Y. Measuring compliance with inhaled medication in asthma. Arch. Dis. Child. 1992. Vol. 67. P. 332-333.

2. Bateman. Controlling asthma. Presented at launch seretid., Berlin, 1999.

3. Woodcock. The rationale for Seretide. Presented at launch seretid, Berlin, 1999.

4.Masoli M., Weatherall M., Holt S., Beasley R. Moderate dose inhaled corticosteroids plus salmeterol versus higher doses of inhaled corticosteroids in symptomatic asthma. Thorax. 2005, Vol. 60 (9). P. 730-734.

5. Kaik G. et al. Annual ERS Congress. 2002 (Poster).

6. Masoli M., Williams M., Weatherall M., Beasley R. The 24h duration of bronchodilator action of the budesonide / formoterol combination inhaler.Respir. Med. 2006. Vol. 100. P. 20-25.

7. Vogelmeier C. D’Urso A., Pauwels R., Merino JM, Jaspal M., Boutet S., Naya I., Price D. Budesonide / formoterol maintenence and reliver therapy: an effective asthma treatment option? // Eur. Respir. J. 2005. Vol. 26. P. 819-828.

8. Johansson G., Andreasson E.B., Larsson P.E., Vogelmeier C.F. Cost effectiveness of budesonide / formoterol for maintenance and reliever therapy versus salmeterol / fluticasone plus salbutamol in the treatment of asthma. Pharmacoeconomics. 2006. Vol. 24 (7). P. 695-708.

9. Ericsson K, Bantje T, Huber R et al. Simbicort Turbuhaler is more cost effective than Fluticasone Discus in the treatment of asthma. Am. J. Respir. Crit. Care Med. 2001. Vol. 163, No. 5. P. A863.

10.O’Sullivan S., Akveld M., Burke C.M., Poulter L.W. Effect of Montelukast to Inhaled Fluticasone Propionate on Airway Inflammation. Am. J. Respir. Crit. Care Med. 2003. Vol. 167. P. 745-750.)

11. Nannini L., Cates C.J., Lasserson T.J., Poole P. Combined corticosteroid and long acting beta-agonist in one inhaler for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2004; 3, CD003794.

90,000 Asthma medicines: an overview of our arsenal to defeat the disease

Let’s take a look at the goals of treatment and the modern arsenal of anti-asthma drugs.So let’s start with the real goals of asthma therapy. Briefly, they boil down to the formula: achieving asthma control . And this is true for a patient of any age, with any initial severity of the condition.

Controlled asthma should behave in such a way as not to be reminded of any symptoms for as long as possible. And the experience of recent years suggests that this lofty goal can be achieved in most patients. Only for this it is necessary for the whole family to work together (with the attending physician).But passive expectation of miracles (for example, complete and final healing or that the child will “outgrow” his illness) is not recommended.

So, for cooperation, we need a common language and self-control tools: a diary of symptoms and peak flowmetry, regular completion of the AST and / or ACQ questionnaires. Unknown words? Refer to the articles in the same section on our website or to your doctor. And within the framework of this little article I will tell you about two groups of anti-asthma drugs.These are BASIC THERAPY (1) and EMERGENCY PREPARATIONS (2) *.

1. BASIC THERAPY MEANS *

The doctor usually prescribes immediately for a long period (months!) With an anti-inflammatory purpose, for daily use, regardless of the presence / absence of asthma manifestations at the moment, for the prevention and not removal of bronchial obstruction. These drugs are the main hopes for achieving asthma control.Moreover, the duration of their use is not limited, there is no concept of “undergoing a course of treatment”: drug support can be used as long as it is needed. So, the BASIC ones include:

• Inhaled glucocorticosteroids = IGCS (“hormones” in the language of beginners): Beclomethasone (Beklazon, Bekotid, Kleniljet), Budesonide (Pulmicort, Budenit-Sterineb, Tafen-novolizer) (2013 to Russia), Flixottedshie g-Mometasone (Astmanex) and Cyclesonide (Alvesco).Today, ICS is a well-studied and “honored” group of drugs. Their arrival in practice about 40 years ago became a real revolution in approaches to the treatment of asthma, because it made it possible to avoid the systemic (oral or intravenous) administration of steroids, but to treat directly the inflamed bronchi! It is no exaggeration to say that ICS is the cornerstone of basic anti-inflammatory therapy for asthma in patients of any age and severity from mild to severe. This group is the first choice for asthma treatment worldwide.
• Antileukotriene drugs = ALTR : Montelukast (Singular, Montelar) and Zafirlukast (Akolat). At present, their features, effects are being actively studied, experience is accumulating for various asthma variants (including physical effort asthma in professional athletes – drugs are allowed by the WADA anti-doping rules), the age threshold for use has been lowered (Montelukast has been used in Russia since 2 years). The most curious feature of the whole group is the tablet form, not the inhaler.Therefore, neither the old nor the little ones have any technical difficulties with taking the medicine. An interesting effect of this group of drugs is the possibility of both independent use and combinations with ICS therapy, which is especially relevant during periods of the “surge” of respiratory viral infections.
• Cromones : Sodium Cromoglycate (Intal, Cromhexal), Sodium Nedocromil (Tayled). Interest in them is retained by the domestic pediatric school – with mild asthma in young children, at the stage of reducing therapy and for the prevention of bronchospasm during physical exertion, with the so-called cough variant of asthma.
• Combinations of ICS with long-acting bronchodilators (ICS + LABA): Seretid, Symbicort, Tevacomb, Foradil-kombi, Foster. Fixed combinations “2 in one” for basic therapy are today the main tool for achieving control over moderate to severe and severe asthma, in the presence of nocturnal symptoms, pronounced hyperreactivity of the bronchi, the impossibility of completely eliminating the action of provoking factors. These medicines are intended to be taken on a daily basis exactly twice a day (morning and evening), as they act just within 10-12 hours after inhalation.Often one drug is produced in different dosages and / or forms, which is very convenient when moving to the next level of therapy (and believe me, the doctor always dreams of a “step down”, that is, reducing the volume of drug therapy).

2. AMBULANCE DRUGS *

Bronchodilators, bronchodilators, bronchospasmolytics, bronchodilators. In contrast, they are used to quickly relieve asthma symptoms in an exacerbation / attack, that is, as needed, rather than routinely.There are not so many drugs in this group: Salbutamol (Ventolin, Salamol), Fenoterol (Berotek), Combined drugs Berodual and Ipramol-Sterineb, as well as pills and injections of Euphyllin. In a few minutes after taking these drugs, they relax the spasmodic smooth muscles of the bronchi, due to which the patency of the airways is restored, air again freely enters the bronchi during inhalation and exhaled during exhalation. But bronchodilators cannot influence other mechanisms of bronchial obstruction – edema of the mucous membrane, secretion of mucus, thickening of the bronchial wall due to inflammation and rearrangement at the cellular level.And they do not have a prophylactic effect, with the exception of the ability to prevent bronchospasm caused by exercise (exercise asthma). The effect – the expansion of the bronchi under the action of bronchodilators – lasts about 3-6 hours. Thus, the more often the patient has to use the ambulance medication, the worse his asthma is controlled.

True, there is also a group of bronchodilators for routine therapy – they do not begin to act so quickly, but they work not 3-6 hours, but all 8-12 hours, and therefore usually the doctor prescribes them 2 times a day for admission for some time (from 5 days to several weeks) and always in combination with ICS – these are: Salmeterol (Serevent), Formoterol (Foradil, Oxis, Atimos), Clenbuterol, Ipratropium (Atrovent, Ipratropium-Sterineb), prolonged theophyllins (Teopek tablets, Theotard, etc.).

As you can see, no universal or ideal medicine has yet been found. New groups of funds are also being investigated and implemented. Each drug, even if assigned to one group, has its own nuances of application, often – its own device for inhalation (metered aerosol or powder inhalers, nebulizer), features of action, advantages and disadvantages.

To tell about everything at once is simply unrealistic, and probably not necessary. After all, we finally got to the most interesting.What is the basis for the choice of a specific medicine for a specific patient?

Clinical guidelines for asthma treatment (international – GINA, Russian – National program) recommend a certain stage of therapy depending on whether asthma control is achieved. Accordingly, over time, both “steps down” (that is, reducing doses, the number of drugs used) and “steps up” in steps (that is, increasing therapy) are possible.

It is necessary to take into account the previous individual experience of the patient himself (tolerance, adverse events, opinion about the effectiveness), the correct use and convenience of the inhalation device, possible age and safety restrictions (in children, in pregnant women and nursing mothers), concomitant diseases and their medication treatment at this time …

So the choice will be made by your attending physician in the process of dialogue with you. And the more active and honest your position is, the faster you will be able to find truly your drug. Be sure to ask the doctor to check the inhalation technique (especially when switching to a new type of device for you or if you have never done it before), grab a diary questionnaire (show your knowledge of self-control!) And discuss the questions that have arisen.

I wish all asthmatics complete control!

* When writing the names of drugs, I give first the internationally patented name, and in brackets – the commercial names.

Yulia Arturovna Yasnova, allergist-immunologist, Center “Paracelsus”

Nativa presented a combined preparation for basic therapy of bronchial asthma

In the spring of 2016 the pharmaceutical company Nativa presented the only Russian combined drug for the treatment of asthma with the active ingredients: budesonide and formoterol. The trade name of the drug is “Formisonide®-native” .

A number of studies have shown that in patients with bronchial asthma (BA) and chronic obstructive pulmonary disease (COPD), exacerbations of varying severity were less often observed when using a fixed combination of budesonide with formoterol in comparison with other combined and non-combined drugs. The active ingredients: budesonide and formoterol – have different mechanisms of action and exhibit an additive effect on the severe symptoms of bronchial asthma, improving lung function and reducing the frequency of exacerbations of diseases.The combination of inhalations of budesonide (200 mcg / day) with formoterol (18 mcg / day) increases the therapeutic efficacy and anti-inflammatory effect in comparison with the monoadmission of budesonide alone at a dosage of 800 mcg per day. ¹

The data of these and other studies served as the basis for the creation of the drug Formisonide®-native, the first and only domestic combination that combines these two components, providing an anti-inflammatory effect, as well as rapidly and long-term expansion of the airways.The special properties of the combined preparation make it possible to use it both as supportive therapy and for relief of seizures, which gives more effective control over the disease, reduces treatment costs, and generally improves the quality of life of patients.

One inhalation dose of Formisonide®-native may contain 80, 160 or 320 μg of budesonide and 4.5 or 9 μg of formoterol. The possibility of dosing the drug (from 1 to 4 inhalations per day) provides flexibility in prescribing therapy, depending on the severity of asthma and allows you to reduce the dose to the minimum required using the same inhaler.

“Formisonide®-native is a popular combination drug for the basic therapy of bronchial asthma. The Russian market for this international non-proprietary name in the form of a metered-dose powder for inhalation in 2015 amounted to about 2 million packages. The Nativa company plans to launch about 500 thousand packages on the market in the second half of 2016, which is about 25% of the market, ” – says Alexander Malin , CEO of Nativa.

The drug is included in the current list of vital and essential drugs (VED) for 2016.

The Ministry of Health of the Russian Federation approved the drug Treleggi Ellipta for the treatment of bronchial asthma.

The first registered in the world ¹ triple combination is now the only one in Russia ² for the treatment of asthma and chronic obstructive pulmonary disease (COPD) ³ . New indication Treleggi Ellipt represents an important alternative in modern asthma therapy.

GSK has announced that the Ministry of Health of the Russian Federation has approved a new indication for the drug Treleggi Ellipta (vilanterol / umeclidinium bromide / fluticasone furoate, VI / UMEC / FF) – “maintenance therapy of bronchial asthma” in patients aged 18 years and older – in addition to the currently registered indication for use as maintenance therapy in patients with COPD ³ . The dosage approved by the Ministry of Health of the Russian Federation for the treatment of COPD and bronchial asthma is 22 μg + 55 μg + 92 μg / dose of vilanterol / umeclidinium / fluticasone furoate. ³

The approval of the new indication means that Treleggi Elliptana has today become the first and only three-component drug in Russia in a single inhaler with a once-daily inhalation regimen, approved simultaneously for the maintenance treatment of bronchial asthma and COPD. ²

Registration of Treleggi Ellipta as an agent for the maintenance therapy of bronchial asthma in patients aged 18 years and older represents a new approach in therapy for about 30% of adult patients with bronchial asthma who still develop symptoms despite adherence to combination therapy with inhaled glucocorticosteroids / long-acting beta-agonists (ICS / LABA). ⁴

Svetlana Klimenko, Medical Director GSK : “In Russia, almost 1.3 million ⁵ adults suffer from bronchial asthma. Many of them continue to live with persisting symptoms and are forced to adjust their lifestyle to them, despite the use of medications prescribed by a doctor. Registration of the indication “maintenance therapy of bronchial asthma” for the innovative three-component drug Treleggi Ellipta opens up unprecedented therapeutic possibilities for these patients. “

The application for registration of an additional indication “bronchial asthma” for the drug Treleggi Ellipta included data from the CAPTAIN study, indicating that in patients without disease control with ICS / LABA, additional bronchodilation provided by Treleggi Ellipta showed significant improvements in lung function when administered a single daily dose of a convenient inhaler in comparison with FF / VI therapy. ⁶ The results of the CAPTAIN study were presented at the European Society of Respiratory Specialists (ERS) Congress in September 2020, and they confirmed the potential of a three-way drug in a single inhaler for once daily asthma treatment.

About bronchial asthma

Bronchial asthma is a chronic lung disease characterized by inflammation and narrowing of the airways.According to the WHO, more than 339 million people worldwide suffer from bronchial asthma. ⁷ Despite advances in medicine, about half of patients fail to achieve disease control and experience severe symptoms that affect their daily life. ⁸

The reasons for the development of bronchial asthma are not fully understood, but they are probably associated with the interaction between the human genetic profile and the environment.The main risk factors are inhaled substances that cause allergic reactions or irritating the respiratory tract. ⁹

Study Information CAPTAIN

The CAPTAIN study (a clinical study in patients with bronchial asthma who received triple therapy using a single inhaler) was a randomized, double-blind, actively controlled international multicenter study in six parallel groups, which evaluated the effect of VI / UMEC / FF (100 / 62.5 / 25 μg, 200 / 62.5 / 25 μg, 100 / 31.25 / 25 μg and 200 / 31.25 / 25 μg) versus FF / VI (100/25 μg and 200/25 μg) prescribed once a day in patients with insufficiently controlled, despite the use of maintenance drugs for the treatment of bronchial asthma – ICS / LABA (> 250 μg / day of fluticasone propionate or its equivalent), bronchial asthma. ⁶

Information about the drug Treledzhi Ellipta (VI / UMEC / FF) in Russia

Vilanterol / umeclidinium bromide / fluticasone furoate (VI / UMEC / FF) is the first registered in the world ¹
a three-component preparation in the form of a single inhaler, which must be used as one inhalation once a day. Treleggi Ellipta is a combination of three components: inhaled glucocorticosteroid (ICS) fluticasone furoate, long-acting anticholinergic drug (DDAC) umeclidinium and long-acting beta agonist ₂ –adrenergic receptors (LADA) vilanterol – for the use of one time Ellipt “by GSK.The registered dose of VI / UMEC / FF is 22 μg + 55 μg + 92 μg. ³

VI / UMEC / FF was approved in the Russian Federation under the trade name Treleggi Ellipta on September 23, 2019 for use as a long-term maintenance therapy in adult patients with moderate to severe COPD that does not sufficiently respond to therapy with combinations of inhaled glucocorticosteroids and long-acting beta ₂ -agonists (ICS / LABA) or long-acting beta ₂ -agonists and long-acting muscarinic receptor antagonists (LABA / LABA). ²

The drug Treleggi Ellipta was approved in the Russian Federation on October 30, 2020 for use as a maintenance therapy for bronchial asthma ² in patients aged 18 years and older. The drug Treleggi Ellipta is not indicated for the relief of acute bronchospasm. ³

On August 5, 2020, Treledji Ellipta was recommended by the Commission of the Ministry of Health of the Russian Federation for the formation of lists of medicines for inclusion in the list of vital and essential medicines (VED) ¹⁰ , and on November 23, 2020.Chairman of the Government of the Russian Federation Mikhail Mishustin signed the corresponding Order No. 3073-r on expanding the list of vital drugs. ¹¹ Thus, Treleggi Ellipta is available to meet the needs of patients with COPD and bronchial asthma within the framework of government subsidized drug provision programs.

GSK Respiratory Disease Commitment

For more than 50 years, GSK has been one of the leaders in the production of medicines that optimize the treatment of COPD and bronchial asthma, including its severe form…. We started with the introduction of the world’s first short-acting selective beta-agonist in 1969 and went on to market six drugs in five years, resulting in one of the best respiratory drug portfolio in the industry. We continue to innovate to provide patients with the drugs they need. Working with the medical community, we are using world-class science to discover the molecules from which the drugs of the future will be developed.We will not stop until something as simple as breathing becomes easier for everyone.

GSK is an international research and development pharmaceutical company that develops and manufactures innovative medicines, vaccines and consumer health products. Millions of people around the world use our products to help them do more, feel better and live longer. GSK is headquartered in the UK. The company operates in more than 150 countries around the world.Out of 100 thousand GSK employees, more than 16 thousand are employees of scientific laboratories. About 80 GSK prescription drugs are registered in Russia. Prescription drugs GSK are used to treat respiratory diseases, infectious diseases, including HIV infection, as well as in the field of urology, immunology, rheumatology, dermatology and vaccine prevention. GSK is one of the industry leaders in terms of investment in research in Russia.

Read more at ru.gsk.com

GSK for Healthcare Professionals: https: // gskpro.com / ru-ru /

Links:

1. Electronic resource: https://www.gsk.com/en-gb/media/press-releases/once-daily-trelegy-ellipta-gains-expanded-copd-indication-in-europe/; https://www.drugs.com/history/trelegy-ellipta.html. Access date: December 2020

2. Electronic resource: http://grls.rosminzdrav.ru/ Access date: December 2020

3. Instructions for the medical use of the drug “Treleggi Ellipta” (dosed powder for inhalation).Registration certificate No. LP-005809 dated 30.10.2020

4. Bateman ED et al. Am J Respir Crit Care Med 2004; 170: 836-844.

5. Electronic resource: https://www.rosminzdrav.ru/ministry/61/22/stranitsa-979/statisticheskie-i-informatsionnye-materialy/statisticheskiy-sbornik-2017-god
Access date: December 2020

6. Lee et al., Lancet Respir Med. 2020 Sep 9; S2213-2600 (20) 30389-1 (Online ahead of print)

7.Electronic resource: https://www.who.int/news-room/fact-sheets/detail/asthma
Access date: December 2020

8. PriceD etal . NPJPrimCareRespirMed 2014; 24: 14009

9. Global Asthma Initiative. Global strategy for the treatment and prevention of bronchial asthma, 2020. Electronic resource: https://www.ginasthma.org. Access date: December 2020

10. Minutes of the meeting of the commission of the Ministry of Health of the Russian Federation on the formation of lists of drugs for medical use and the minimum range of drugs required for the provision of medical care, dated August 5, 2020.Electronic resource: https://minzdrav.gov.ru/ministry/61/10/stranitsa-858/protokol-zasedaniya-komissii-ministerstva-zdravoohraneniya-rossiyskoy-federatsii-po-formirovaniyu-perechney-lekarstvennyh-premedparatovinsk-ogd -primeneniya-i-minimalnogo-assortimenta-lekarstvennyh-preparatov-neobhodimyh-dlya-okazaniya-meditsinskoy-pomoschi-ot-5-avgusta-2020-goda. Access date: 11.08.

11. Order of the Government of the Russian Federation of November 23, 2020 No. 3073-r http: //static.government.ru / media / files / XSa8p7I5b5HKbAYd2xmfvVzBsosxagSe.pdf. Access date: December 2020

Brief instructions for the use of the drug Treleggi Ellipta

BRIEF INSTRUCTIONS FOR MEDICAL APPLICATION OF TRELEGY ELLIPTA PREPARATION No. LP 005809 dated 09/23/2019

Trade name of the drug. Treleggi Ellipt

International non-proprietary name (INN). Vilanterol + umeclidinium bromide + fluticasone furoate.

Dosage form. Dosed powder for inhalation.

Indications for use.

Bronchial asthma

Supportive therapy for bronchial asthma.

COPD (chronic obstructive pulmonary disease)

Maintenance therapy in adults with moderate to severe COPD who do not sufficiently respond to therapy with combined inhaled glucocorticosteroids and long-acting beta2-agonists or combined long-acting beta2-agonists and long-acting muscarinic receptor antagonists.

Contraindications The drug is contraindicated in patients with a history of severe allergic reactions to milk protein; patients with a history of hypersensitivity to vilanterol, umeclidinium, fluticasone furoate or any other component of the drug • children under 18 years of age.

Carefully. patients with severe cardiovascular diseases, angle-closure glaucoma or urinary retention, convulsive syndrome or thyrotoxicosis and patients with an atypical reaction to beta2-adrenergic receptor agonists, patients with pulmonary tuberculosis, as well as chronic or untreated infections, patients with impaired liver function moderate or severe.

Application during pregnancy and during breastfeeding. Data on the use of the drug Treleggi Ellipta in pregnant women are limited. In preclinical studies, reproductive toxicity during exposure has been identified that is not clinically significant. The use of the drug Treleggi Ellipta in pregnant women is permissible only if the expected benefit to the mother outweighs the potential risk to the fetus. It is not known whether vilanterol, umeclidinium, fluticasone furoate or their metabolites are excreted in human breast milk.The risk to newborn / breastfed babies cannot be excluded. It is necessary to make a decision either to discontinue the drug Treleggi Ellipta, or to stop breastfeeding, taking into account the benefits of therapy for the mother and the benefits of breastfeeding for the baby.

Method of administration and dosage. intended for inhalation use only. The recommended and maximum dose is one inhalation of Treleggi Ellipta once a day at the same time of the day.After inhalation, the patient should rinse the mouth with water without swallowing it.

Side effect. Often: pneumonia, upper respiratory tract infection, bronchitis, pharyngitis, rhinitis, sinusitis, influenza, nasopharyngitis, oral and throat candidiasis, urinary tract infection, headache, cough, oropharyngeal pain, constipation, arthralgia, back pain. The incidence of pneumonia with Treleggi Ellipta is comparable to that observed with a combination of vilanterol and fluticasone furoate at a dosage of 22 μg + 92 μg / dose in clinical trials for COPD.Uncommon: viral respiratory tract infection, supraventricular tachyarrhythmia, tachycardia, atrial fibrillation, dysphonia, dryness of the oral mucosa, fractures.

Overdose. An overdose of Treleggi Ellipt can cause the development of signs, symptoms or undesirable effects due to the pharmacological action of the individual components of the drug. There is no specific treatment for an overdose with Treleggi Ellipta. In case of overdose, if necessary, supportive treatment should be carried out with proper supervision.

Interaction with other drugs. When the drug is prescribed in therapeutic doses, clinically significant drug interactions of vilanterol, umeclidinium or fluticasone furoate are considered unlikely due to the low concentrations of these substances in the blood plasma when administered by inhalation. Beta-blockers can weaken or interfere with the action of beta2-adrenergic agonists such as vilanterol. If it is necessary to use beta-blockers, the use of cardioselective beta-blockers should be considered; however, caution should be exercised with the simultaneous use of both non-selective and selective beta-blockers.The concomitant use of Treleggi Ellipt and other long-acting antimuscarinic drugs or long-acting beta2-adrenergic receptor agonists has not been studied and is not recommended, since it can increase unwanted reactions.

Release form, conditions of release from the pharmacy. Dosed powder for inhalation, 22 mcg + 55 mcg + 92 mcg / dose. On prescription

If you would like to report an adverse event related to the use of GSK products, please contact: 125167, g.Moscow, Leningradsky prospect, 37a, building 4, BC “Arkus III” – JSC “GlaxoSmithKline Trading”; or by phone: +7 495 777-89-00, fax +7 495 777-89-04; or by e-mail: [email protected], or to the Federal Service for Surveillance in Healthcare at the address: 109074, Moscow, Slavyanskaya Square, 4, building 1, or by phone: +7 495 698-45- 38, +7 495 578-02-30, or by e-mail: [email protected].

The trademark is owned by the GSK group of companies or used under license by the GSK group of companies.

Modern approaches to the diagnosis and treatment of bronchial asthma in adults

Bronchial asthma is one of the most widespread diseases of mankind. The analysis of the causes of death from bronchial asthma testifies, first of all, to insufficient basic anti-inflammatory therapy, as well as to urgent urgent care not provided in a timely manner in case of an exacerbation of the disease. Underdiagnosis of asthma necessitates constant updating of knowledge about the basic principles of diagnosis and treatment of asthma.

The main reason for underdiagnosis of asthma is the underestimation of the lungs and rare episodes of bronchial asthma, which leads to a late diagnosis, when there is already a moderate or severe course of the disease. There is no standardized physiological test that would have high sensitivity and specificity for the diagnosis of bronchial asthma.

Bronchial asthma is a chronic inflammatory disease of the airways, in which many cells and cellular elements take part.Chronic inflammation leads to the development of bronchial hyperreactivity, which leads to repeated episodes of wheezing, shortness of breath, chest congestion and coughing, especially at night and in the early morning. These episodes are usually associated with widespread but variable airway obstruction in the lungs, which is often reversible, either spontaneously or with treatment.

Asthma directly related to immunological mechanisms should be called allergic .

Bronchial asthma not associated with exoallergens is called endogenous bronchial asthma.

Distinguish by severity:

a) intermittent (stage 1): attacks less than 2 times a week, exacerbations are short, from several hours to several days, nocturnal attacks are rare – 2 times or less a month, forced expiratory volume is at least 80% of normal.

b) persistent (stage 2): attacks not every day, no more than 2 per week, nighttime symptoms more than 2 times a month, forced expiratory volume 80% of normal.

2) the average degree (stage 3) manifests itself every day, requires daily use of bronchodilators, night attacks more often than 1 time per week, forced expiratory volume from 60% to 80% of normal.

3) Severe degree (stage 4) – bronchial obstruction, expressed in varying degrees, constant, limiting physical activity, forced expiratory volume of 60% or less of normal.

According to the degree of control over the disease, there are:

– well controlled bronchial asthma

– partially controlled bronchial asthma

– uncontrolled bronchial asthma.

Based on the level of control, a decision is made to intensify therapy, or, conversely, with good control, begin to reduce dosages.

Modern principles of bronchial asthma therapy in adults:

Means for the rapid relief of bronchial asthma:

– fast acting B – adrenergic agonists

– anticholinergics

– combined preparations of inhaled B2 – adrenomimetics and ipratropium bromide.

Inhaled B2 agonists of rapid action are the drugs of choice for the relief of acute bronchospasm, as well as for the prevention of exercise-induced bronchospasm, the duration of their bronchodilator effect lasts only 6 hours. These drugs are recommended to be prescribed only as needed, which should be minimal. The growing, especially daily use of these drugs indicates a loss of control of bronchial asthma and requires a revision of therapy.

Short-acting inhaled anticholinergics are less effective in relieving bronchospasm than fast-acting B2 agonists.

Long-term asthma control (anti-inflammatory drugs):

– inhaled and systemic corticosteroids

– Long acting B2 agonists in combination with inhaled corticosteroids.

Inhaled glucocorticosteroids form the basis of basic anti-inflammatory therapy, prevent the development of symptoms and exacerbations of the disease. They are indicated for the treatment of persistent bronchial asthma of any severity and allow complete control, however, they do not cure asthma and stopping them often leads to the return of symptoms of the disease.The effect is dose-dependent. However, with increasing doses of inhaled glucocorticosteroids, the risk of unwanted side effects increases.

As a result, the strategy of adding drugs of another class to inhaled glucocorticosteroids turned out to be more acceptable. The most effective is the combination of inhaled glucocorticosteroids and a long-acting B2 agonist.

Systemic glucocorticosteroids are not recommended for the maintenance therapy of bronchial asthma due to the development of side effects.These drugs are used to treat severe exacerbations.

In the pulmonary department of the State Budgetary Healthcare Institution “TOKB im. V.D. Babenko ”treatment of bronchial asthma is carried out using modern drug therapy schemes, taking into account the clinical phenotypes of the disease. Nebulizer therapy for bronchodilators and steroids has been introduced with the selection of optimal regimens for the outpatient stage. Introduced the use of inhalation drugs with new delivery methods (spiriva – respimat), long-acting M-anticholinergics in patients with severe persistent bronchial asthma.All this makes it possible to successfully treat about 400 patients a year with this not a simple disease and achieve a good clinical effect.