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Effectiveness and Safety of Bronchial Thermoplasty in the Treatment of Severe Asthma

A Multicenter, Randomized, Double-Blind, Sham-Controlled Clinical Trial

¹ Division of Pulmonary and Critical Care Medicine, Washington University School of Medicine, St. Louis, Missouri; ² Irmandade Santa Casa de Misericórdia da Porto Alegre, Porto Alegre, Brazil; ³ Laval Hospital, Laval University, Quebec, Canada; ⁴ Hospital São Lucas da PUCRS, Porto Alegre, Brazil; ⁵ Hospital Universitário Clementino Fraga Filho, Rio de Janeiro, 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, Quebec, Canada; ⁹ Gartnavel General Hospital, University of Glasgow, Glasgow, United Kingdom; ¹⁰ University Hospital of South Manchester and 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; ¹³ Pulmonary and Medical Associate of Northern Virginia, Arlington, Virginia; ¹⁴ HealthPartners Specialty Center, St. Paul, Minnesota; ¹⁵ Division of Pulmonary and Critical Care Medicine, Keck School of Medicine of the University of Southern California, Los Angeles, California; ¹⁶ Department of Pulmonary Diseases, Universtair Medisch Centrum, Groningen, the Netherlands; ¹⁷ Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts; 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; ²¹ Baylor College of Medicine, Houston, Texas; ²² Division of Pulmonary and Critical Care Medicine, University of Wisconsin, Madison, Wisconsin; ²³ Duke University Medical Center, Durham, North Carolina; ²⁴ Asthmatx, Inc., Sunnyvale, California; ²⁵ QST Consultations, Ltd, Allendale, Michigan; ²⁶ Berry Consultants, LLC, College Station, Texas; and ²⁷ St. Joseph's Healthcare, McMaster University, Hamilton, Ontario, Canada

Correspondence and requests for reprints should be addressed to Mario Castro, M.D., M.P.H., Washington University School of Medicine, Campus Box 8052, 660 S. Euclid, St. Louis, MO 63110-1093. E-mail: castrom{at}wustl.edu

Rationale: Bronchial thermoplasty (BT) is a bronchoscopic procedure in which controlled thermal energy is applied to the airway wall to decrease smooth muscle.

Objectives: To evaluate the effectiveness and safety of BT versus a sham procedure in subjects with severe asthma who remain symptomatic despite treatment with high-dose inhaled corticosteroids and long-acting β₂-agonists.

Methods: A total of 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 health care use were collected to assess safety. Statistical design and analysis of the primary endpoint was Bayesian. Target posterior probability of superiority (PPS) of BT over sham was 95%, except for the primary endpoint (96.4%).

Measurements and Main Results: The improvement from baseline in the integrated AQLQ score was superior in the BT group compared with sham (BT, 1.35 ± 1.10; sham, 1.16 ± 1.23 [PPS, 96.0% ITT and 97.9% per protocol]). Seventy-nine percent of BT and 64% of sham subjects achieved changes in AQLQ of 0.5 or greater (PPS, 99.6%). Six percent more BT subjects were hospitalized in the treatment period (up to 6 wk after BT). In the posttreatment period (6–52 wk after BT), the BT group experienced fewer severe exacerbations, emergency department (ED) visits, and days missed from work/school compared with the sham group (PPS, 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 use in the posttreatment period.

Clinical trial registered with www.clinialtrials.gov (NCT00231114).

Key Words: asthma • Alair Bronchial Thermoplasty System • bronchial thermoplasty • bronchoscopic procedure • Asthma Quality of Life

AT A GLANCE COMMENTARY Scientific Knowledge on the Subject Bronchial thermoplasty is a novel intervention for asthma that delivers controlled thermal energy to the airway wall during a series of bronchoscopy procedures. What This Study Adds to the Field The current study reflects one of the largest sham-controlled trials in pulmonary medicine to test a novel device to perform bronchial thermoplasty, a procedure for the treatment of severe asthma. Bronchial thermoplasty improves asthma-specific quality of life and decreases severe exacerbations in patients with severe asthma.

 

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