Asthma and lower airway disease
Bronchial thermoplasty: Long-term safety and effectiveness in patients with severe persistent asthma

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Background

Bronchial thermoplasty (BT) has previously been shown to improve asthma control out to 2 years in patients with severe persistent asthma.

Objective

We sought to assess the effectiveness and safety of BT in asthmatic patients 5 years after therapy.

Methods

BT-treated subjects from the Asthma Intervention Research 2 trial (ClinicalTrials.gov NCT01350414) were evaluated annually for 5 years to assess the long-term safety of BT and the durability of its treatment effect. Outcomes assessed after BT included severe exacerbations, adverse events, health care use, spirometric data, and high-resolution computed tomographic scans.

Results

One hundred sixty-two (85.3%) of 190 BT-treated subjects from the Asthma Intervention Research 2 trial completed 5 years of follow-up. The proportion of subjects experiencing severe exacerbations and emergency department (ED) visits and the rates of events in each of years 1 to 5 remained low and were less than those observed in the 12 months before BT treatment (average 5-year reduction in proportions: 44% for exacerbations and 78% for ED visits). Respiratory adverse events and respiratory-related hospitalizations remained unchanged in years 2 through 5 compared with the first year after BT. Prebronchodilator FEV1 values remained stable between years 1 and 5 after BT, despite a 18% reduction in average daily inhaled corticosteroid dose. High-resolution computed tomographic scans from baseline to 5 years after BT showed no structural abnormalities that could be attributed to BT.

Conclusions

These data demonstrate the 5-year durability of the benefits of BT with regard to both asthma control (based on maintained reduction in severe exacerbations and ED visits for respiratory symptoms) and safety. BT has become an important addition to our treatment armamentarium and should be considered for patients with severe persistent asthma who remain symptomatic despite taking inhaled corticosteroids and long-acting β2-agonists.

Section snippets

Study procedures

Subjects undergoing BT in the AIR2 trial were followed to 5 years. The study population and design of the AIR2 trial have been published.7 Data collected during the 5-year follow-up and episodes of severe exacerbations were analyzed by using a noninferiority approach to demonstrate that the benefit of BT in the year after the procedure was maintained in each of the subsequent years out to 5 years (ClinicalTrials.gov no. NCT01350414).

On completion of the year 1 evaluation in the AIR2 trial,

Results

Of the 190 subjects who underwent BT treatment in the AIR2 trial, 162 (85.3%) completed the 5-year follow-up. The number of subjects undergoing BT and completing annual follow-up at years 1, 2, 3, 4, and 5 was 181, 165, 162, 159, and 162, respectively. Twenty-eight (14.7%) subjects undergoing BT did not complete the year 5 evaluation (18 were lost to follow-up, 4 were withdrawn by the investigators [terminal illness: 1; noncompliance with physician's instructions: 3], 5 were withdrawn for

Discussion

In this study we examined the long-term follow-up of patients who underwent BT in the AIR2 trial7 through an open-label observation of posttherapy events. Previously published data have demonstrated the persistent benefits of BT out to 2 years in patients with severe persistent asthma.9 This study demonstrates an improvement in asthma control as measured by a maintained reduction in the proportion of subjects experiencing severe exacerbations that persists out to at least 5 years after BT.

References (20)

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Cited by (0)

Supported by Boston Scientific Corporation, Sunnyvale, Calif.

Disclosure of potential conflict of interest: M. E. Wechsler has consultant arrangements with GlaxoSmithKline (GSK), Novartis, Cephalon/Teva, Sepracor/Sunovion, NKY Therapeutics, Asthmatx/BSCI, Genzyme, MapPharma, Genentech, Boehringer Ingelheim, Merck, Cytos, and MedImmune and receives payment for lectures from Merck. M. Laviolette has received grants from Novartis and Merck and has received travel support from Merck. A. S. Rubin is a board member for Boehringer Ingelheim; has consultant arrangements with Novartis and Boehringer Ingelheim; receives payment for lectures from GSK, Novartis, AstraZeneca, Boehringer Ingelheim, and ACHE; and receives payment for development of educational presentations from InterMune, AstraZeneca, GSK, Novartis, Bayer, and Boehringer Ingelheim. J. Fiterman has received grants from Asthmatx, Novartis, Takeda, and Cephalon; has received payment for development of educational presentations from ACHE; and has received travel expenses from ACHE, Novartis, Takeda, and GSK. J. R. Lapa e Silva has received grants from Asthmatx and the National Institutes of Health (NIH), has consultant arrangements with Takeda, is employed by the Federal University of Rio de Janeiro, and has received travel expenses from Takeda. P. L. Shah has received a grant from Boston Scientific; is on the advisory board for Olympus; has received payment for lectures from Novartis and Boston Scientific; has been reimbursed for clinical trial expenses by PneumRX; and has received sponsorship for a bronchoscopy course at Imperial College from ERBE, Cook Medical, Superdimension, Olympus, and PneumRX. E. Fiss is a board member for Pfizer and has received travel expenses from GSK, Merck Sharp Dohme, Roche, Boehringer, and ACHE. R. Olivenstein has received a grant from McGill University Health Center. N. C. Thomson has received grants from Asthmatx, Aerovance, AstraZeneca, GSK, MedImmune, Novartis, and Synairgen; is on the advisory board for Boston Scientific; is a board member for Asmacure, Chiesi, and Respivert; has received payment for lectures from AstraZeneca, Boston Scientific, Chiesi, GSK, and Novartis; and has received travel expenses from Novartis and Nycomed. R. M. Niven has received payment for lectures from GSK, Novartis, Vectura, Chiesi, and Boston Scientific and has received travel expenses from GSK, Novartis, Boehringer, Chiesi, and Boston Scientific. I. D. Pavord has received a grant from Asthmatx; is a board member for Almirall, AstraZeneca, Boehringer Ingelheim, 220 GSK, Merck Sharp Dohme, Schering-Plough, Novartis, Dey, and Napp; has consultant arrangements with Almirall, AstraZenca, Boehringer Ingelheim, 220 GSK, Merck Sharp Dohme, Schering-Plough, Novartis, Dey, and Napp; and has received payment for lectures from AstraZeneca, Boehringer Ingelheim, GSK, Boston Scientific, and Aerocrine. M. Simoff received reimbursement for the costs of the study from Asthmatx, is on the medical advisory board for and has received grants from Varian Medical, and has received royalties from Blackwell Publishing. J. B. Hales has received a grant from Virginia Hospital Center, has received travel support from Pulm Med Associates of Northern Virginia, and has received payment for lectures from Bronchial Thermoplasty Preceptorships. C. McEvoy has received grants from HealthPartners Institute of Education and Research; the National Heart, Lung, and Blood Institute; GSK; and Boston Scientific. D.-J. Slebos has received travel reimbursement and speakers' fees from Boston Scientific. M. J. Phillips has received a grant and travel support from WA Lung Research. N. A. Hanania has received a grant from Baylor College of Medicine and has received payment for lectures from Merck, Genentech, and GSK. K. Sumino has received grants from Veterans Affairs, the NIH, and the American Lung Association Asthma Clinical Research Center and has received payment for lectures from Astellas Japan. M. Kraft has received grants from the NIH, Genentech, GSK, Merck, Asthmatx, Eumedics, and Novartis and receives a stipend from the American Thoracic Society. G. Cox has received grants from Asthmatx/BSCI and has consultant arrangements with and has received travel support from Boston Scientific. K. Hogarth has a research contract with Asthmatx, has received grants and payment for lectures from Boston Scientific, and has preceptorships to train in BT from Boston Scientific. J. N. Kline has received a grant and travel support from Asthmatx and has received grants from GSK, Teva, Boehringer Ingelheim, Pearl Therapeutics, and Genentech. A. H. Mansur has received Asthma Intervention Research 2 trial participation cost fees. B. E. Louie has received payment for lectures from Intuitive Surgical and Merit Endotek. W. M. Leeds has board memberships with the Washburn University Advisory Board and Xyrem Pharmaceuticals; has received grants from Asthmatx, Rox Medical, Apnex Medical, BioCryst Pharmaceuticals, Aeris Therapeutics, Broncus Technologies, Boehringer-Ingelheim, Forest Research Institution, GSK, PulmonX, Sunovion Pharmaceuticals, Merck, Sharpe & Dohme, and Novartis Pharmaceuticals; and has received payment for lectures from the Kansas Medical Association of Sleep Professionals, the Kansas Medical Education Foundation, the Veterans Affairs Administration, GSK, and Forest Pharmaceuticals. J. H. M. Austin has received consulting fees or honorarium and support for travel to meetings from Boston Scientific. N. S. Shargill is employed by and receives stock/stock options from Boston Scientific. J. Quiring and B. Armstrong have consulting arrangements with and have received travel support and fees for participation in review activities, writing, and reviewing the manuscript from Asthmatx. M. Castro has received grants from the NIH, the American Lung Association, Asthmatx/Boston Scientific, Amgen, Ception/Cephalon, Teva, Genentech, MedImmune, Merck, Novartis, GSK, Sanofi-Aventis, and Vectura; has received travel support from the NIH; has consultant arrangements with Asthmatx, Genentech, IPS, Pulmagen, and Sanofi-Aventis; has received payment for lectures from Pfizer, Merck, GSK, Genentech, and Asthmatx/Boston Scientific; and receives royalties from Elsevier. The rest of the authors declare that they have no relevant conflicts of interest.

∗

A list of the members of the Asthma Intervention Research 2 Trial Study Group can be found at the end of this article.

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