Alair® Bronchial Thermoplasty System by Asthmatx

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What is the AIR2 Trial?
The AIR2 Trial: The objective of this randomized, double blind, sham-controlled study is to evaluate the safety and efficacy of Bronchial Thermoplasty with the Alair® System in a population of subjects with severe asthma who are still symptomatic despite being managed on conventional therapy.

Pavord I, Cox G, Thomson N, et al, Safety and Efficacy of Bronchial Thermoplasty in Symptomatic, Severe Asthma, Am. J. Respir. Crit. Care Med 2007;176:1185-1191

Safety and Efficacy of Bronchial Thermoplasty in Symptomatic, Severe Asthma

Ian D. Pavord¹, Gerard Cox², Neil C. Thomson³, Adalberto S. Rubin⁴, Paul A. Corris⁵, Robert M. Niven⁶, Kian F. Chung⁷, Michel Laviolette⁸ and the RISA Trial Study Group*

¹Glenfield General Hospital, University Hospitals of Leicester NHS Trust, Leicester, United Kingdom; ²St. Joseph's Healthcare-McMaster University, Hamilton, Canada; ³Gartnavel General Hospital, University of Glasgow, Glasgow, United Kingdom; ⁴Irmandade Santa Casa de Misericórdia, Porto Alegre, Brazil; ⁵Institute of Cellular Medicine, Newcastle University, Newcastle-upon-Tyne, United Kingdom; ⁶Wythenshawe Hospital, University of Manchester, Manchester, United Kingdom; ⁷National Heart and Lung Institute, Imperial College, London, United Kingdom; and ⁸Laval Hospital, Laval University, Quebec, Canada

Correspondence and requests for reprints should be addressed to Ian D. Pavord, M.D., Glenfield General Hospital, University Hospitals of Leicester NHS Trust, Groby Road, Leicester LE3 9QP, United Kingdom. E-mail: ian.pavord@uhl-tr.nhs.uk

Abstract

Rationale: Bronchial thermoplasty (BT) is designed to reduce airway smooth muscle and improve asthma control.

Objectives: This study was conducted to determine the safety and efficacy of this procedure in subjects with symptomatic, severe asthma.

Methods: Adults who were symptomatic despite treatment with fluticasone or equivalent at more than 750 µg/day, a long-acting β₂-agonist, and other medications, which could include 30 mg or less of oral prednisolone/day, were randomized to BT or to a control group. After treatment, subjects entered a 16-week steroid stable phase (Weeks 6-22), a 14-week steroid wean phase (Weeks 22-36), and a 16-week reduced steroid phase (Weeks 36-52).

Measurements and Main Results: BT resulted in a transient worsening of asthma symptoms. Seven hospitalizations for respiratory symptoms occurred in 4 of 15 BT subjects during the treatment period. Five hospitalizations were within 3 days of treatment. Two subjects had segmental collapse involving the most recently treated lobe; one required bronchoscopy and aspiration of a mucus plug. There were no hospitalizations during this period in the 17 control subjects. The rate of hospitalizations was similar in both groups in the post-treatment period. At 22 weeks, BT subjects had significant improvements versus control subjects in rescue medication use(-26.6±40.4 vs. -1.5±11.7 puffs/7 d, P<0.05) , prebronchodilator FEV1% predicted (14.9±17.4 vs. -0.94±22.3%, P=0.04), and Asthma Control Questionnaire scores (-1.04±1.03 vs. -0.13±1.00, P=0.02). Improvements in rescue medication use and Asthma Control Questionnaire scores remained significantly different from those of controls at 52 weeks.

Conclusions: BT is associated with a short-term increase in asthma-related morbidity. However, there is preliminary evidence of long-lasting improvement in asthma control.

Clinical trial registered with www.clinicaltrials.gov (NCT 00214539).

Key Words: bronchial thermoplasty • asthma • bronchoscopy • airway smooth muscle • radiofrequency energy