Asthma Control during the Year after Bronchial Thermoplasty
Gerard Cox, M.B., Neil C. Thomson, M.D., Adalberto S. Rubin, M.D., Robert M. Niven, M.D., Paul A. Corris, M.D., Hans Christian Siersted, M.D., Ronald Olivenstein, M.D., Ian D. Pavord, M.D., David McCormack, M.D., Rekha Chaudhuri, M.D., John D. Miller, M.D., Michel Laviolette, M.D., for the AIR Trial Study Group
Background Bronchial thermoplasty is a bronchoscopic procedureto reduce the mass of airway smooth muscle and attenuate bronchoconstriction.We examined the effect of bronchial thermoplasty on the controlof moderate or severe persistent asthma.
Methods We randomly assigned 112 subjects who had been treatedwith inhaled corticosteroids and long-acting 2-adrenergic agonists(LABA) and in whom asthma control was impaired when the LABAwere withdrawn to either bronchial thermoplasty or a controlgroup. The primary outcome was the frequency of mild exacerbations,calculated during three scheduled 2-week periods of abstinencefrom LABA at 3, 6, and 12 months. Airflow, airway responsiveness,asthma symptoms, the number of symptom-free days, use of rescuemedication, and scores on the Asthma Quality of Life Questionnaire(AQLQ) and the Asthma Control Questionnaire (ACQ) were alsoassessed.
Results The mean rate of mild exacerbations, as compared withbaseline, was reduced in the bronchial-thermoplasty group butwas unchanged in the control group (change in frequency persubject per week, –0.16±0.37 vs. 0.04±0.29;P=0.005). At 12 months, there were significantly greater improvementsin the bronchial-thermoplasty group than in the control groupin the morning peak expiratory flow (39.3±48.7 vs. 8.5±44.2liters per minute), scores on the AQLQ (1.3±1.0 vs. 0.6±1.1)and ACQ (reduction, 1.2±1.0 vs. 0.5±1.0), thepercentage of symptom-free days (40.6±39.7 vs. 17.0±37.9),and symptom scores (reduction, 1.9±2.1 vs. 0.7±2.5)while fewer puffs of rescue medication were required. Valuesfor airway responsiveness and forced expiratory volume in 1second did not differ significantly between the two groups.Adverse events immediately after treatment were more commonin the bronchial-thermoplasty group than in the control groupbut were similar during the period from 6 weeks to 12 monthsafter treatment.
Conclusions Bronchial thermoplasty in subjects with moderateor severe asthma results in an improvement in asthma control.(ClinicalTrials.gov number, NCT00214526
[ClinicalTrials.gov]
.)
Source Information
From St. Joseph's Healthcare, McMaster University, Hamilton, ON, Canada (G.C., J.D.M.); Gartnavel General Hospital, University of Glasgow, Glasgow, United Kingdom (N.C.T., R.C.); Irmandade Santa Casa de Misericórdia, Porto Alegre, Brazil (A.S.R.); Wythenshawe Hospital, University of Manchester, Manchester, United Kingdom (R.M.N.); Institute of Cellular Medicine, Newcastle University, Newcastle-upon-Tyne, United Kingdom (P.A.C.); Odense University Hospital, Odense, Denmark (H.C.S.); Montreal Chest Institute, Montreal (R.O.); Glenfield General Hospital, University Hospitals of Leicester National Health Service Trust, Leicester, United Kingdom (I.D.P.); London Health Science Centre, London, ON, Canada (D.M.); and Laval Hospital, Laval University, Quebec, QC, Canada (M.L.).
Address reprint requests to Dr. Cox at the Firestone Institute for Respiratory Health, St. Joseph's Healthcare and McMaster University, 50 Charlton Ave. E., Rm. T2123, Hamilton, ON L8N 4A6, Canada, or at coxp{at}mcmaster.ca.
Bronchial Thermoplasty
Macklem P. T., Medford A. R.L., Agrawal A., Cox G., Thomson N. C., Laviolette M.
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N Engl J Med 2007;
356:2744-2745, Jun 28, 2007.
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