Health InsurancePivotal Data Show Bronchial Thermoplasty Can Improve Quality Of Life And Reduce Asthma Attacks And Emergency Room Visits For Adults With Severe Asthma
Results of the Asthma Intervention Research 2 (AIR2) Trial of the Alair(R) Bronchial Thermoplasty System, developed by Asthmatx, Inc., were announced at ATS 2009, the International Conference of the American Thoracic Society, in San Diego, Calif. The AIR2 results demonstrated statistically significant improvements in quality of life measurements, reductions in asthma attacks (severe exacerbations) and emergency room visits for respiratory symptoms in adults with severe asthma who underwent bronchial thermoplasty delivered by the Alair System.
"The reduction in asthma attacks and improvements in quality of life are consistent with the outcomes from previous trials," said Mario Castro, MD, Professor of Medicine and Pediatrics at the Washington University School of Medicine, and a Principal Investigator in the AIR2 Trial. "These outcomes provide further clinical evidence needed to demonstrate the safety, effectiveness and long term benefits of bronchial thermoplasty."
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.
"The results from AIR2, similar to the results from two prior randomized clinical trials evaluating the Alair System, demonstrate that patients with severe asthma can experience clinically significant improvements in their asthma control and their quality of life," said Glen French, CEO of Asthmatx.
The results of this pivotal study have enabled Asthmatx to submit a Premarket Approval application (PMA) to the FDA for regulatory approval. The FDA granted the Alair System PMA Expedited Review Status in October 2008, based on its potential "to treat asthma, a life-threatening/debilitating disease" and because the "Alair System offers a breakthrough technology which has the potential to address an unmet clinical need within the asthma population."
"Participation in the AIR2 Trial required an extraordinary level of involvement from all patients, and we were encouraged by the very high level of interest from patients who wanted to participate," said Dr. Castro, Principal Investigator at Washington University, St. Louis, the largest enrolling site in the U.S. "This high level of patient interest and involvement in this complex and time-consuming trial reflects the substantial clinical need that exists for new treatment options in this population of patients with severe asthma."
About Bronchial Thermoplasty Delivered by the Alair System
Bronchial thermoplasty is a non-drug procedure for asthma. The treatment is performed through the working channel of a standard flexible bronchoscope that is introduced through a patient"s nose or mouth, and into their lungs. The tip of the small diameter Alair(R) catheter is expanded to contact the walls of targeted airways. Controlled thermal energy is then delivered to the airway walls to reduce the presence of airway smooth muscle that narrows the airways in patients with asthma. The minimally invasive procedure, like many other flexible endoscopy procedures, is done under light anesthesia, and the patient returns home the same day.
CAUTION: Alair System is an Investigational Device. It is limited by United States law to investigational use. To be used by Qualified Investigators only.
Alair is a registered trademark of Asthmatx, Inc.
About Asthmatx
Asthmatx is developing catheter-based medical devices for the treatment of asthma. Asthmatx has developed the Alair System to perform an investigational outpatient procedure called bronchial thermoplasty. The Alair System from Asthmatx was awarded "Best of 2006" by Popular Science Magazine and Bronchial Thermoplasty was named one of the "Top Ten Medical Innovations for 2007" by the prestigious Cleveland Clinic Foundation. The Alair System has received a CE Mark for use in the European Union.
Asthmatx, Inc