Published ahead of print on October 8, 2009 Am. J. Respir. Crit. Care Med. 2009, doi:10.1164/rccm.200903-0354OC
Submitted on March 5, 2009 Effectiveness and Safety of Bronchial Thermoplasty in the Treatment of Severe Asthma: A Multicenter, Randomized, Double-Blind, Sham-Controlled Clinical TrialMario Castro1*,1 Division of Pulmonary and Critical Care Medicine, Washington University School of Medicine, St Louis, Missouri, United States, 2 Irmandade Santa Casa de Misericórdia da Porto Alegre,, Porto Alegre, Brazil, 3 Laval Hospital, Laval University, Quebec City, Canada, 4 Hospital São Lucas da PUCRS, Porto Alegre, Brazil, 5 Hospital Universitário Clementino Fraga Filho, Rio de Janiero, Brazil, 6 Chelsea & Westminster Hospital NHS Foundation Trust, London, United Kingdom, 7 Faculdade de Medicina do ABC, Santo André, Sao Paulo, Brazil, 8 Montreal Chest Institute, Montreal, Canada, 9 Gartnavel General Hospital, University of Glasgow, Glasgow, United Kingdom, 10 Wythenshawe Hospital, University of Manchester, Manchester, United Kingdom, 11 Glenfield General Hospital, University Hospitals of Leicester NHS Trust, Leicester, United Kingdom, 12 Henry Ford Medical Center, Detroit, Michigan, United States, 13 Pulmonary and Medical Associate of Northern Virginia, Arlington, Virginia, United States, 14 HealthPartners Specialty Center, St. Paul, Minnesota, United States, 15 Division of Pulmonary and Critical Care Medicine, Keck School of Medicine of the University of Southern California, Los Angeles, California, United States, 16 Universitair Medisch Centrum Groningen, Groningen, Netherlands, 17 Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, United States, 18 Respiratory Clinical Trials Unit, Royal Adelaide Hospital, Adelaide, Australia, 19 Western Australia Lung Research, Sir Charles Gairdner Hospital, Perth, Australia, 20 Department of Pulmonary and Critical Care Medicine, Cleveland Clinic, Cleveland, Ohio, United States, 21 Baylor College of Medicine, Houston, Texas, United States, 22 Division of Pulmonary and Critical Care Medicine, University of Wisconsin, Madison, Wisconsin, United States, 23 Duke University Medical Center, Durham, North Carolina, United States, 24 Berry Consultants, LLC, College Station, Texas, United States, 25 QST Consultations, Ltd, Allendale, Michigan, United States, 26 Asthmatx, Inc.,, Sunnyvale, California, United States, 27 St. Joseph’s Healthcare, McMaster University, Hamilton, Canada * To whom correspondence should be addressed. E-mail: castrom{at}im.wustl.edu.
Background: Bronchial thermoplasty (BT) is a bronchoscopic procedure in which controlled thermal energy is applied to the airway wall to decrease smooth muscle.
Objective: Evaluate the effectiveness and safety of BT versus sham procedure in subjects with severe asthma who remain symptomatic despite treatment with high-dose inhaled corticosteroids and long-acting Key words: asthma • safety and effectiveness • Alair Bronchial Thermoplasty System • bronchial thermoplasty • bronchoscopic procedure
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2-agonists.
Methods: 288 adult subjects (Intent-to-Treat (ITT)) randomized to BT or sham control underwent three bronchoscopy procedures. Primary outcome was the difference in Asthma Quality of Life Questionnaire (AQLQ) scores from baseline to average of 6-, 9-, and 12-months (integrated AQLQ). Adverse events and healthcare utilization were collected to assess safety. Statistical design and analysis of the primary endpoint was Bayesian. Target posterior probability of superiority (ppsuperiority) of BT over sham was 95%, except for the primary endpoint (96.4%).
Results: The improvement from baseline in the integrated AQLQ score was superior in the BT group compared to sham (BT: 1.35±1.10; sham: 1.16±1.23 (ppsuperiority 96.0% (ITT) and 97.9% (per protocol)). 79% of BT and 64% of sham subjects achieved changes in AQLQ of 
0.5 (ppsuperiority 99.6%). 6% more BT subjects were hospitalized in the treatment period (up to 6 weeks after BT). In the post-treatment period (6–52 weeks after BT), the BT group experienced fewer severe exacerbations, emergency department (ED) visits and days missed from work/school compared to sham (ppsuperiority: 95.5%, 99.9%, and 99.3%, respectively).
Conclusions: BT in subjects with severe asthma improves asthma-specific quality of life with a reduction in severe exacerbations and healthcare utilization in the post-treatment period.