10.1186_1471-2466-11-8.pdf (233.56 kB)
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Long-term (5 year) safety of bronchial thermoplasty: Asthma Intervention Research (AIR) trial

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posted on 08.11.2013, 10:41 by N.C. Thomson, A.S. Rubin, R.M. Niven, P.A. Corris, H.C. Siersted, R. Olivenstein, Ian D. Pavord, D. McCormack, M. Laviolette, N.S. Shargill, G. Cox, the AIR Trial Study Group
Background: 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. Methods: 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. Results: 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 FEV[subscript 1] values showed no deterioration over the 5 year period in the BT group. Similar results were obtained for the Control group. Conclusions: The absence of clinical complications (based on AE reporting) and the maintenance of stable lung function (no deterioration of FVC and FEV[subscript 1]) 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.



BMC Pulmonary Medicine, 2011, 11 : 8


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