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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.

Cox G, Miller J, McWilliams A, et al, Bronchial Thermoplasty for Asthma, Am J Resp Crit Care Med 2006;173:965-969

Bronchial Thermoplasty for Asthma

Gerard Cox, John D. Miller, Annette McWilliams, J. Mark FitzGerald and Stephen Lam

Firestone Institute for Respiratory Health, St. Joseph's Healthcare, McMaster University, Hamilton, Ontario; and Vancouver General Hospital, University of British Columbia, Vancouver, British Columbia, Canada

Abstract

Rationale: Bronchial thermoplasty (BT) reduces the potential for smooth muscle–mediated bronchoconstriction by reducing the mass of smooth muscle in the walls of conducting airways.

Objectives: This study was conducted to examine the safety and impact on lung function and airway responsiveness of BT over 2 yr.

Methods: The safety of BT was studied in 16 subjects with mild to moderate asthma. Baseline and 12-wk post-treatment measurements included spirometry, methacholine challenge, daily diary recordings of peak flow, symptoms, and medication usage. Subjects completed follow-up evaluations at 12 wk, 1 yr, and 2 yr.

Measurements and Main Results: The procedure was well tolerated; side effects were transient and typical of what is commonly observed after bronchoscopy. All subjects demonstrated improvement in airway responsiveness. The mean PC20 increased by 2.37 ± 1.72 (p < 0.001), 2.77 ± 1.53 (p = 0.007), and 2.64 ± 1.52 doublings (p < 0.001), at 12 wk, 1 yr, and 2 yr post-procedure, respectively. Data from daily diaries collected for 12 wk indicated significant improvements over baseline in symptom-free days (p = 0.015), morning peak flow (p = 0.01), and evening peak flow (p 0.007). Spirometry measurements remained stable throughout the study period.

Conclusions: BT is well tolerated in patients with asthma and results in decreased airway hyperresponsiveness that persists for at least 2 yr.

Key Words

airway smooth muscle • asthma • bronchoscopy • radiofrequency energy

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