Long-term (5 year) safety of bronchial thermoplasty: Asthma Intervention Research (AIR) trial

Patients enrolled in the Asthma Intervention Research Trial were on inhaled corticosteroids ≥200 μg beclomethasone or equivalent + long-acting-beta2-agonists and demonstrated worsening of asthma on long-acting-β2-agonist withdrawal. Following initial evaluation at 1 year, subjects were invited to participate in a 4 year safety study. Adverse events (AEs) and spirometry data were used to assess long-term safety out to 5 years post-BT.45 of 52 treated and 24 of 49 control group subjects participated in long-term follow-up of 5 years and 3 years respectively. The rate of respiratory adverse events (AEs/subject) was stable in years 2 to 5 following BT (1.2, 1.3, 1.2, and 1.1, respectively,). There was no increase in hospitalizations or emergency room visits for respiratory symptoms in Years 2, 3, 4, and 5 compared to Year 1. The FVC and FEV1 values showed no deterioration over the 5 year period in the BT group. Similar results were obtained for the Control group.The absence of clinical complications (based on AE reporting) and the maintenance of stable lung function (no deterioration of FVC and FEV1) over a 5-year period post-BT in this group of patients with moderate to severe asthma support the long-term safety of the procedure out to 5 years.Asthma continues to be a major health concern worldwide, with over 23 million people in the United States who suffer with this disease [1]. Approximately 5-10% of these patients are characterized as having severe persistent asthma based on continued presence of asthma symptoms despite treatment with current state-of-the-art medications [2]. Poorly controlled asthma impacts the patient's quality of life, increases healthcare utilization, and imposes both a social as well as an economic burden [3-8].The recent approval of the Alair？ Bronchial Thermoplasty System for delivering bronchial thermoplasty (BT) provides an additional option for managing patients with severe asthma. BT provides therapeutic benefit by reducing the amount of