Bronchial thermoplasty (BT), which is the first device-based asthma treatment approved by the FDA, is an outpatient procedure that delivers precisely controlled thermal energy to reduce excess airway smooth muscle that is associated with airway constriction in patients with asthma. By decreasing the ability of the airways to constrict, the new treatment has been shown to help patients with severe asthma gain substantially better control over the disease.

Asthmatx said that the FDA approval of the Alair System was based on the promising results of the AIR2 Trial, a double-blind, randomized study designed to evaluate the safety and effectiveness of bronchial thermoplasty in adult patients with severe asthma.

The trial demonstrated that patients treated with the Alair System not only improved their asthma quality of life over patients who rely solely on medical therapy after one year, but the patients also experienced other clinically significant benefits.

In the trial period immediately following bronchial thermoplasty, there was an expected transient increase in the frequency and worsening of respiratory-related symptoms, which were of the type expected following bronchoscopy in patients with asthma. Investigators in the AIR2 Trial concluded that the increased risk of adverse events in the short-term following bronchial thermoplasty is outweighed by the benefits, which persist for at least one year.

Mario Castro, professor of medicine and pediatrics at the Washington University School of Medicine, and principal investigator of the AIR2 Trial, said: “Approval of the Alair System for bronchial thermoplasty will enable clinicians to provide a much needed treatment option to their patients with severe asthma.

“These are patients who, despite receiving high levels of asthma medications, continue to suffer from asthma attacks, which often result in emergency room visits and impose significant limitations on their daily activities. Bronchial thermoplasty offers these patients an important new way to control their disease.”

Glen French, CEO of Asthmatx, said: “After more than a decade of careful research and four separate clinical studies, the FDA approval marks the final step in bringing this first-of-its-kind treatment option to patients with an unmet medical need. We look forward to continuing to work closely with asthma and pulmonary experts to address the needs of patients with this debilitating disease.”