The AIR2 Trial was designed to evaluate the safety and effectiveness of bronchial thermoplasty in adult patients with severe asthma who were symptomatic, despite being treated with high doses of standard of care medications (high dose inhaled corticosteroids and long-acting bronchodilators). The study was a randomized, double-blind, sham-controlled trial and enrolled 297 patients at 30 sites in 6 countries. The primary effectiveness endpoint was the change from baseline in Asthma Quality of Life Questionnaire (AQLQ) score. Safety was assessed by comparing the short and long-term safety profiles for both the treatment and sham control groups.
Key statistically significant clinical findings of the AIR2 Trial were:
Improvement in the average AQLQ score at 6-, 9-, and 12 months over sham control;
4 out of 5 Alair-treated patients responded with a clinically significant improvement in AQLQ compared to 64% of sham controls;
32% reduction in asthma attacks;
84% reduction in emergency room visits for respiratory symptoms;
36% reduction in patients reporting episodes of asthma (multiple symptoms) adverse events;
66% reduction in days lost from work/school or other activities due to respiratory symptoms.
In the period immediately following bronchial thermoplasty, there is an expected increase and worsening of respiratory-related symptoms, which are of the type expected following bronchoscopy in patients with asthma. These events typically occur within a day of the procedure and resolve on average within 7 days with standard care. In the long term, fewer bronchial thermoplasty treated patients reported respiratory adverse events and there was a significant decrease in patients reporting asthma (multiple symptoms) adverse events in the Alair-treated group compared to the sham control group.