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

Neil C Thomson, Adalberto S Rubin, Robert M Niven, Paul A Corris, Hans Christian Siersted, Ronald Olivenstein, Ian D Pavord, David McCormack, Michel Laviolette, Narinder S Shargill, Gerard Cox, AIR Trial Study Group, P G Cardoso, M Cavalcanti, P R D Soares, S Zelmanovitz, P Nair, S Goodwin, S Keogh, M Kjarsgard, J Bourbeau, F Houghton, R Mangaser, N Patterson, S Metha, J Howard, L MacBean, S Martel, L-P Boulet, S Savord, L Morel, L Trepanier, F Rasmussen, H M Christensen, S Bicknell, R Chaudhuri, E Hothersall, J Lafferty, J Jarvis, C Prys-Picard, G Fletcher, A Fletcher, B Higgins, T Small, B Foggo, L Mackay, S Parker, M Berry, D Shaw, P Haldar, A Charalambou, M Hopkin, A Raj, N Yousaf, N Goodman, B Armstrong, J Quiring, W Busse, R Schellenberg, Scott Berry, A S Slutsky, Neil C Thomson, Adalberto S Rubin, Robert M Niven, Paul A Corris, Hans Christian Siersted, Ronald Olivenstein, Ian D Pavord, David McCormack, Michel Laviolette, Narinder S Shargill, Gerard Cox, AIR Trial Study Group, P G Cardoso, M Cavalcanti, P R D Soares, S Zelmanovitz, P Nair, S Goodwin, S Keogh, M Kjarsgard, J Bourbeau, F Houghton, R Mangaser, N Patterson, S Metha, J Howard, L MacBean, S Martel, L-P Boulet, S Savord, L Morel, L Trepanier, F Rasmussen, H M Christensen, S Bicknell, R Chaudhuri, E Hothersall, J Lafferty, J Jarvis, C Prys-Picard, G Fletcher, A Fletcher, B Higgins, T Small, B Foggo, L Mackay, S Parker, M Berry, D Shaw, P Haldar, A Charalambou, M Hopkin, A Raj, N Yousaf, N Goodman, B Armstrong, J Quiring, W Busse, R Schellenberg, Scott Berry, A S Slutsky

Abstract

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 FEV1 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 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.

Figures

Figure 1
Figure 1
FEV1 and FVC over Time. Post-bronchodilator FEV1 and FVC over time. Data represent group mean values for each year.. Note that participation of the Control subjects in the study was terminated after Year 3 evaluation.

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