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About Severe Asthma

What is severe asthma?

Severe asthma affects a small number of asthma patients, but those patients with severe asthma experience more asthma-related symptoms, attacks, and deaths. Severe asthma does not always respond easily to long-term controller medicines. Patients with severe asthma often need large doses of multiple medications to control their asthma, and still may have serious asthma symptoms. Severe asthma really affects a patient's quality of life. It can make the most basic daily activities a struggle and can make sleeping at night difficult due to frequent asthma symptoms.

Patients with severe asthma experience frequent symptoms such as coughing, wheezing, shortness of breath, chest tightness, mucus production, and exacerbations (asthma attacks) caused by a narrowing of the lungs' airways.

Patients who are severely affected by asthma are 4 times as likely to experience negative outcomes, such as emergency room visits, hospitalizations, and use of oral steroids.1 On average, a patients will spend 4 days in the hospital each time they are admitted for asthma treatment.2

What is an asthma attack?

An asthma attack is characterized by swelling of the airways or constriction of the muscle within the airway wall in the lungs, so that the airways become narrowed. A person having an asthma attack may feel a tightening in the chest and may experience wheezing and coughing, and may have trouble breathing.3  While mild asthma attacks usually respond to rescue medication, severe asthma attacks typically require treatment with oral steroids.

What role does airway smooth muscle play during an asthma attack?

The airways in the lung have a spiral layer of muscle within the wall of the airway. People with asthma may have more airway smooth muscle than people who don't have asthma.3,4 During an asthma attack, this excess muscle tissue constricts, thereby narrowing the airways and making it harder to breathe.3

About Bronchial Thermoplasty

What is Bronchial Thermoplasty?

Bronchial Thermoplasty, delivered by the Alair™ System, is a safe and effective outpatient procedure that provides a long-lasting reduction in severe asthma attacks for adults with severe asthma who are not well controlled with maintenance medications. Fewer severe asthma attacks means less need for the associated oral steroid treatment — and its side effects.

How does Bronchial Thermoplasty work?

Bronchial Thermoplasty (BT) reduces the amount of excess smooth muscle tissue in the airways. Thus in response to an asthma trigger, there is less constriction or narrowing of the airways, so breathing is easier, and there is less likelihood of a severe asthma attack. This is different from asthma medicines that work by opening up the airways by reducing swelling or causing the muscle in the airway wall to relax; although these medicines don't always work well in people who have severe asthma.

What are the benefits of Bronchial Thermoplasty?

In a clinical trial of patients with severe asthma, 79% of patients treated with BT reported significant improvements in their asthma-related quality of life. The clinical trial also showed that patients experienced reductions in severe asthma attacks, ER visits and hospitalizations for respiratory symptoms, and fewer days lost from work, school, and other daily activities due to asthma.5 The reductions in asthma attacks and ER visits continue to last for at least 5 years.6

What are the risks of the Bronchial Thermoplasty procedure?

As with any procedure, there are risks, and individual results may vary. The most common side effect of BT is a temporary worsening of respiratory-related symptoms that typically occurs within 1 day of the procedure and resolves within 7 days on average with standard care.

There is a small risk (3.4%) of these symptoms requiring hospitalization around the time of the BT procedure.

Who Benefits from BT?

Am I a candidate for Bronchial Thermoplasty?

BT delivered by the Alair™ System was approved by the FDA in 2010 for the treatment of severe persistent asthma in patients 18 years and older whose asthma is not well controlled with inhaled corticosteroids and long-acting beta-agonists such as Advair™, Symbicort™, and Dulera™.

A thorough evaluation with your asthma physician or a physician trained in BT will first help determine if you have severe asthma, are taking the appropriate medication to treat your asthma, and are taking your medication as prescribed. If you continue to exhibit asthma symptoms despite taking your medication appropriately, you may be a candidate for BT, and should discuss it with your asthma physician.

Some patients still experience frequent asthma attacks and their quality of life is significantly impacted, despite the fact that they take the right medications for their asthma.

BT is for:

Patients who are on maximum tolerated doses of combined ICS and LABA's such as Advair™, Dulera™, and Symbicort™, and who may also experience one or more of the following:

  • Patients who take oral steroids for asthma attacks more than twice a year
  • Patients who do not qualify for or do not respond to Anti-IgE therapy
  • Patients who take oral steroids as daily maintenance medication

About the Procedure

What will happen during the Bronchial Thermoplasty procedure?

To ensure safety every step of the way, BT is typically performed under moderate sedation in three separate sessions scheduled three weeks apart. Each session lasts about an hour and focuses on a different part of the lung to ensure all of the reachable airways are treated. No incision is required to perform this procedure. The catheter is introduced into your airways through a bronchoscope that is inserted through your mouth or nose. The physician performing the procedure will carefully treat along the length of the airways in the part of the lung planned to be treated in each of the sessions. After the procedure, you will be carefully monitored for 2 to 4 hours and discharged on the same day. The treating physician will provide you with more details on what to expect during and after the procedure.

What could delay a Bronchial Thermoplasty procedure?

Your scheduled procedure could be postponed for another time if:

  • you have an active respiratory infection
  • you have a bleeding disorder
  • you've had an asthma attack in the past 14 days
  • you have had an increased or decreased dose of oral steroids for asthma in the past 14 days
  • your doctor says you cannot stop taking the following medications prior to the BT procedure: anticoagulants, antiplatelet agents, aspirin, or non-steroidal anti-inflammatory medications (NSAIDS)."

Who performs Bronchial Thermoplasty?

BT is performed at an outpatient hospital facility by a BT-certified and experienced pulmonologist who is specially trained to perform bronchoscopy procedures and Bronchial Thermoplasty. To find a BT Clinic and treating physician near you, visit: Find a BT Clinic

Will I be able to stop taking my asthma medications?

You will not be able to stop your daily asthma medications after BT. BT does not replace your current daily maintenance medication, but instead works with it to provide long-term stability in your asthma symptoms and to reduce severe asthma attacks requiring oral steroids (prednisone).

What makes Bronchial Thermoplasty different from asthma medications?

  • Short-term (rescue) asthma medications offer temporary relief by relaxing the airway muscle so that it does not narrow the airways during an asthma attack.
  • BT is a non-drug procedure that works with your asthma medications to reduce your likelihood of experiencing serious asthma symptoms.
  • BT, delivered by the Alair™ System, is a safe outpatient procedure that uses mild heat to reduce the amount of excess airway smooth muscle tissue in the airways. Learn more about how BT is performed. Thus in response to an asthma trigger, there is less constriction or narrowing of the airways, so breathing is easier, and there is less likelihood of an asthma attack.5
  • Fewer severe asthma attacks means less need for the associated oral steroid treatment — and the related side effects."
  • In a clinical trial in patients with severe asthma, BT was proven to reduce severe asthma attacks, emergency rooms visits for respiratory symptoms, and time lost from work, school, and other activities due to asthma symptoms.5

Is Bronchial Thermoplasty covered by insurance?

Coverage policies and payment vary by payer. Your BT physician and the staff at the BT Clinic will work with you to request and pursue coverage for your BT procedure.

Other Options

What are the current treatment options for severe asthma?

Many drugs can be prescribed to manage asthma symptoms. The severity of a patient's asthma often plays a large role in what medications are prescribed and how successful those medications will be.

Some major types of asthma medications include:

  • Anti-inflammatory drugs. Inhaled corticosteroids are the key drugs used for controlling the underlying inflammation in asthma.
  • Bronchodilators widen the airways by relaxing airway smooth muscle, though they do not reverse airway inflammation. Bronchodilators come in 2 basic forms:
    • Maintenance medications such as long-acting beta-agonists that work up to 12 hours.
    • Rescue (short-acting) medications that work quickly to ease severe asthma symptoms for 4 to 6 hours.
  • Medications for long-term control, including methylxanthines, anticholinergics, leukotriene inhibitors, and Anti-IgE therapy such as Xolair™.
  • Oral corticosteroids such as prednisone, when used for maintenance, are reserved for patients with severe asthma. These drugs typically serve as maintenance medications.

What are the side effects of oral steroids and other asthma medications?

Asthma medications can have potentially serious side effects. As with any medication, side effects become a greater concern when treatment is ongoing and as dosages increase, which is often the case for patients with severe asthma.

  • Corticosteroids (oral steroids): Side effects of prednisone and other oral corticosteroids range from mild annoyances to serious, irreversible damage. These side effects occur more frequently with higher doses and longer treatment. Side effects with ongoing use include suppression of the immune system, adrenal system, and growth; osteoporosis; skin thinning; hypertension; cataracts; glaucoma; muscle weakness; and increased risk of infection. Short-term side effects include stomach upset, headache, dizziness, trouble sleeping, fluid retention, weight gain, high blood pressure, loss of potassium, elevation of cholesterol levels, and vision changes.
  • Bronchodilators: The possible side effects of short-acting rescue medications include rapid heartbeat, skeletal muscle tremor, potassium deficiency, increased lactic acid, headache, and hyperglycemia. Long-acting beta-agonists may even cause severe asthma symptoms in some patients, and death when those episodes occur.2
  • Other drugs: The side effects of Anti-IgE therapy (omalizumab, Xolair™) include anaphylaxis (severe allergic reaction), injection-site reactions, and viral infections.

Is BT right for you?

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References:

  1. Schatz M, et al, J Allergy Clin Immunol. 2011; 128:44
  2. National hospital discharge survey, Centers for Disease Control. 2009
  3. Cox P, et al. Eur Respir J. 2004;24:659-663
  4. Woodruff P, et al. Am J Respir Crit Care Med. 2004;169:1001-1006.
  5. Castro M, et al, for the AIR2 Trial Study Group. Am J Respir Crit Care Med. 2010;181:116-124
  6. Wechsler M, et al; for the AIR2 Trial Study Group Journal of Asthma and Clinical Immunology, August 2013

Brief Statement of Relevant Indications for Use, Contraindications, Warnings, and Adverse Events: The Alair™ Bronchial Thermoplasty System is indicated for the treatment of severe persistent asthma in patients 18 years and older whose asthma is not well controlled with inhaled corticosteroids and long-acting beta-agonists. The Alair System is not for use in patients with an active implantable electronic device or known sensitivity to medications used in bronchoscopy. Previously treated airways of the lung should not be retreated with the Alair System. Patients should be stable and suitable to undergo bronchoscopy. The most common side effect of BT is an expected transient increase in the frequency and worsening of respiratory-related symptoms.

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