BT delivered by the Alair™ System is clinically proven to be a safe and effective treatment for severe asthma, with long-lasting benefits

Asthma Intervention Research 2 (AIR2) Trial: In this trial, one of the largest sham-controlled medical device trials in pulmonary medicine, patients with severe asthma showed significant improvement compared to sham-controlled patients one year after treatment with BT.1

 

 
BT is Clinically Effective

Clinically effective

Asthma experts around the world talk about the effectiveness of BT.
 

Proven to last at least 5 years

Reduction in percentage of patients experiencing exacerbations seen at 1 year maintained for at least 5 years (primary endpoint).2

Additionally, there was a 44% decrease (average over 5 years) in the percentage of BT-treated patients having severe exacerbations, compared with 12 months prior to BT treatment.2

Reduction in ER visits seen at 1 year maintained for at least 5 years.2

Additionally, there was a 78% decrease (average over 5 years) in the percentage of BT-treated patients experiencing ER visits for respiratory symptoms, compared with 12 months prior to BT treatment.2

 

Proven safety

Asthma experts around the world say BT is safe.

No increase was seen in hospitalizations, asthma symptoms, or respiratory adverse events over the course of 5 years in patients treated with Bronchial Thermoplasty delivered by the Alair System.2

No structural changes in the airways that were clinically significant were due to BT at 5 years.2

Absence of clinically significant deterioration in lung function (pre-bronchodilator FEV1) at 5 years.2

 Proven Safety

Robust clinical research for a non-drug therapy in severe asthma clearly demonstrates the long-lasting benefit of BT

Bronchial Thermoplasty is supported by 4 completed clinical studies, and one ongoing, in asthma patients all with 5 year follow up: 3 of the trials were randomized, controlled, clinical trials.
Clinical Trials Timeline
AIR2 Trial
AIR2 Trial
AIR2 Trial Extension Study
AIR2 Trial Extension Study
RISA Trial
RISA Trial
Clinical meeting

Understand 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 temporary worsening of respiratory-related symptoms. This side effect typically occurs within a day of the procedure and resolves within 7 days on average with standard care. There is a small (3.4% per procedure) risk of these symptoms requiring hospitalization.1
As with any procedure, there are risks, and individual results may vary. The most common side effect of BT is temporary worsening of respiratory-related symptoms. This side effect typically occurs within a day of the procedure and resolves within 7 days on average with standard care. There is a small (3.4% per procedure) risk of these symptoms requiring hospitalization.1

BT has been published in a variety of well-known and respected peer reviewed journals

The Journal of Allergy and Clinical Immunology
The Journal of Respiratory and Critical Care Medicine
Other Publications
See more on how BT works
Brief Statement of Relevant Indications for Use, Contraindications, Warnings, and Adverse Events: The Alair™ Bronchial ThermoplastySystem 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. ENDO-551804-AA 
As with any procedure, there are risks, and individual results may vary. The most common adverse event of BT is a temporary worsening of respiratory-related symptoms. These events typically occur within one day of the BT procedure and usually resolve within a week with standard care. There is a small risk (3.4% per procedure) that symptoms may require hospitalization.1

References

  1. Castro M, et al, for the AIR2 Trial Study Group. Am J Respir Crit Care Med. 2010;181:116-124.
  2. Wechsler M et al. J Allergy Clin Immunol. 2013 Dec;132(6):1295-302.
  3. Chupp G, et al. Eur Respir J. 2017;50:1700017.
  4. Castro M, et al, for the AIR2 Trial Study Group. Ann Allergy Asthma Immunol. 2011;107:65-70.
  5. Pavord I, et al, and the RISA Trial Study Group. Am J Respir Care Med. 2007;176:1185-1191.
  6. Cox G, et al. N Engl J Med. 2007;356:1327-1337.
  7. Thomson N, et al, for the AIR Trial Study Group. BMC Pulm Med. 2011;1-9.
  8. Cox G, et al. Am J Respir Crit Care Med. 2006;173:965-969.
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