Asthmatx, Inc., a medical device company that has developed a catheter-based procedure for the treatment of asthma, announced today the successful completion of enrollment in its pivotal FDA approved IDE study, the Asthma Intervention Research 2 (AIR2) Trial of the Alair? Bronchial Thermoplasty System. Bronchial Thermoplasty is a non-drug treatment for asthma under clinical investigation in the United States.
The minimally invasive, bronchoscopic procedure uses thermal energy to reduce the airway smooth muscle responsible for constriction in asthma patients.
Leading asthma and bronchoscopy experts are participating in this international, multicenter AIR2 Trial to establish the safety and efficacy of the Alair System. Nearly 300 patients were enrolled in the study during the last 18 months at over 30 world-renowned medical centers including 15 US research hospitals. The AIR2 Trial is the fourth clinical study of the Alair Bronchial Thermoplasty System. To date, over 700 bronchoscopic procedures have been performed on asthma patients.
“We are very pleased to be a participant in this very important AIR2 Trial, the success of which will result in an important advancement in the treatment of severe asthma,” states Mario Castro, MD, Associate Professor at the Washington University School of Medicine and Asthma Center, and a Principal Investigator in the AIR2 Trial. “As the lead enrolling center in the United States, we have experienced significant patient interest in bronchial thermoplasty, which we hope may become a new option for patients with difficult-to-treat asthma.”
Final results of the first randomized and controlled clinical study of bronchial thermoplasty, the Asthma Intervention Research (AIR) Trial, were also reported today at the annual scientific assembly of the American Thoracic Society (ATS) by Gerard Cox, MB, Professor of Medicine, McMaster University, Canada, and principal investigator of the AIR Trial. These important milestones for Asthmatx follow the March publication of the AIR Trial results in the New England Journal of Medicine (NEJM ). The data from this international multi-center study showed that in the year after bronchial thermoplasty, compared to their baseline status, patients treated with the outpatient procedure demonstrated a:
50% decrease in asthma attacks, from 18/year to 9/year,45% reduction in rescue medication use, from 20 puffs/week to 11 puffs/week of short-acting bronchodilators,2.6 fold increase in days with no asthma symptoms, from 3 months with no asthma symptoms to 8 months with no asthma symptoms,Clinically significant improvements in both asthma quality of life and asthma control.
In the period immediately following bronchial thermoplasty, there was an expected increase and worsening of respiratory-related symptoms such as breathlessness, wheeze, cough, chest discomfort, night awakenings, and productive cough. These symptoms were of the type expected following bronchoscopy in patients with asthma, and resolved on average within 7 days with either no therapy or with standard medical care. The frequency and types of respiratory-related adverse events were similar in both groups from 6 weeks after the treatment out to one year.
“We treated the first patient five years ago and have participated in each of the four clinical studies of the Alair System. Our experience suggests that the Bronchial Thermoplasty procedure is quite well-tolerated, and that it may hold considerable promise for patients with severe asthma,” says Gerard Cox, M.B., Professor of Medicine, McMaster University, Canada, lead author of the NEJM publication and a Principal Investigator in the AIR2 Trial.