FDA approves Alair Bronchial Thermoplasty System for severe persistent asthmaAsthmatx announced that the FDA has approved the Alair Bronchial Thermoplasty System for the treatment of severe persistent asthma in patients ≥18 years of age whose asthma is not well controlled with inhaled corticosteroids and long acting beta agonists, the current standard-of-care treatment for these patients. This approval was based on the 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 AIR2 Trial demonstrated that patients treated with the Alair System improved their asthma quality of life over patients who rely solely on medical therapy after one year. Additionally, these patients also experienced: a 32% reduction in asthma attacks; an 84% reduction in emergency room visits for respiratory symptoms; a 73% reduction in hospitalizations for respiratory symptoms; and a 66% reduction in days lost from work/school or other daily activities due to asthma.
Bronchial thermoplasty (BT), a device-based asthma treatment approved by the FDA, is a novel 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, this new treatment has been shown to help patients with severe asthma gain substantially better control over their disease.
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