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

Thomson, N.C. et al. (2011) Long term (5 Year) safety of bronchial thermoplasty: Asthma Intervention Research (AIR) trial. BMC Pulmonary Medicine, 11(8), (doi: 10.1186/1471-2466-11-8)

Abstract

<b>Background:</b> Bronchial thermoplasty (BT) is a bronchoscopic procedure that improves asthma control by reducing excess airway smooth muscle. Treated patients have been followed out to 5 years to evaluate long-term safety of this procedure. <br></br> <br></br> <b>Methods:</b> 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. <br></br> <br></br> <b>Results:</b> 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. <br></br><br></br> <b>Conclusions:</b> 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.

• Item Type: Articles
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: Thomson, Professor Neil
• Authors: Thomson, N.C., Rubin, A.S., Niven, R.M., Corris, P.A., Siersted, H.C., Olivenstein, R., Pavord, I.D., McCormick, D., Laviolette, M., Shargill, N.S., and Cox, G.
• College/School: College of Medical Veterinary and Life Sciences > School of Infection & Immunity
• Research Group: The AIR Trial Study Group
• Journal Name: BMC Pulmonary Medicine
• Publisher: BioMed Central
• ISSN: 1471-2466
• First Published: First published in BMC Pulmonary Medicine 11(1):8
• Publisher Policy: Reproduced in accordance with the copyright policy of the publisher