New 5 Year Data
Exacerbations reducedER visits decreasedSafety Maintained


Established long-term effectiveness and safety:
5 years of clinical trial follow-up data
12+ years of clinical experience

Asthma Intervention Research 2 (AIR2) Trial: At 1 year, patients with severe asthma showed significant improvement in their asthma-related quality of life after treatment with Bronchial Thermoplasty (BT) delivered by the Alair™ System:

  • Quality of life improvement: 79% of patients who were treated with BT reported a significant improvement in their asthma-related quality of life1
  • Fewer absences: 66% fewer asthma-related days lost from work, school, and other activities, compared with sham-controlled patients1

AIR2 Trial 5-Year Extension Study: This study evaluated the sustained effectiveness of BT beyond 1 year, and the safety of BT out to 5 years in the BT-treated patients from the AIR2 Trial.2

Fewer exacerbations, with effectiveness maintained out to 5 years

  • 32% decrease in severe asthma exacerbations (requiring systemic corticosteroids) at 1 year, compared with sham-controlled patients1
  • Reduction in exacerbations seen at 1 year maintained out to 5 years2

    44% average decrease over 5 years in the percentage of patients having severe exacerbations, compared with 1 year prior to BT treatment2

48% average decrease in severe exacerbation event rate

5-year reduction in severe exacerbations requiring systemic corticosteroids

  • The decrease in severe exacerbations over 5 years included a substantial reduction in the use of systemic corticosteroids associated with those exacerbations2
  • Fewer asthma exacerbations means reduced need for the associated oral steroid treatment and its side effects

Fewer emergency room visits, with reduction maintained out to 5 years

  • 84% reduction in emergency room visits for respiratory symptoms at 1 year, compared to sham-controlled patients1
  • Reduction in ER visits seen at 1 year maintained out to 5 years2

    78% average decrease over 5 years in the percentage of patients experiencing ER visits for respiratory symptoms, compared with 1 year prior to BT treatment2

88% average decrease in ER visits for respiratory symptoms

Safety maintained over 5 years

  • No increase was seen in hospitalizations, asthma symptoms, or respiratory adverse events over the course of 5 years2
  • No structural changes in airways that were clinically significant were due to BT at 5 years (based on high-resolution HRCT review)2
  • No clinically significant deterioration in lung function (FEV1) at 5 years2

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.

Click here to view 5 year data publication

Clinical studies for BT

BT has been studied in a rigorous, stepwise fashion beginning with animal studies, followed by 4 clinical studies in asthma patients, 3 of which were randomized, controlled clinical trials, and all with 5 years of follow-up. Two clinical studies focused on the severe asthma patient population.

The Asthma Intervention Research 2 (AIR2) Trial is one of the largest sham-controlled medical device trials in pulmonary medicine. At 1 year, patients with severe asthma treated with BT showed significant improvement compared to sham-controlled patients.1,2

‡ Asthma Intervention Research (AIR)

§ Research in Severe Asthma (RISA)

Selected studies are shown below. Click on the individual trial name below for additional information on each clinical study.

AIR2 Trial

RISA Trial

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; for the AIR2 Trial Study Group [published ahead of print September, 2013].
J Allergy Clin Immunol. doi:10.1016/j.jaci.2013.08.009.

3. Cox G, et al. Am J Respir Crit Care Med. 2006;173:965-969.

4. Cox G, et al. N Engl J Med. 2007;356:1327-1337.

5. Thomson N, et al, for the AIR Trial Study Group. BMC Pulm Med. 2011;1-9.

6. Pavord I, et al, and the RISA Trial Study Group. Am J Respir Care Med. 2007;176:1185-1191.

7. Castro M, et al, for the AIR2 Trial Study Group. Ann Allergy Asthma Immunol. 2011;107:65-70.