Study Results
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View full resultsBasic Information
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COMPLETED
NA
297 participants
INTERVENTIONAL
2005-09-30
2013-04-30
Brief Summary
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The primary efficacy endpoint will be the difference between Study groups in the change in Asthma Quality of Life Questionnaire (AQLQ) score from Baseline and the average score from the 6-, 9-, and 12-month follow-up visits.
All other outcome measures assessed at 12 months post-treatment.
This will be a multicenter, randomized, double-blind, sham-controlled study comparing the effects of treatment with the Alair System to conventional therapy of inhaled corticosteroids (ICS) and long-acting β2-agonists (LABA).
A Bayesian adaptive approach to sample size selection is used with a randomization scheme of 2:1 (two Alair Group Subjects for every one Control Group Subject).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Alair
Treatment of airways with the Alair System
Alair System
Treatment of airways with the Alair System
Sham
Sham treatment of airways
Alair System
Sham treatment of airways with the Alair System
Interventions
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Alair System
Treatment of airways with the Alair System
Alair System
Sham treatment of airways with the Alair System
Eligibility Criteria
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Inclusion Criteria
* Subject has asthma and is taking regular maintenance medication that includes Inhaled corticosteroid (ICS) AND long acting ß2-agonist (LABA).
* Subject has a Pre-bronchodilator Forced Expiratory Volume in one second (FEV1) of greater than or equal to 60% of predicted after medication stabilization during the Baseline Period.
* Subject has a PC20 \< 8 mg/ml per methacholine inhalation test using standardized methods. PC20 is a provocative concentration of Provocholine® (a brand of methacholine chloride) resulting in a drop of FEV1 of 20% or more from Baseline.
* Subject has at least two days of asthma symptoms during the 4-weeks of the Baseline Diary Period.
* Subject is a non-smoker for 1 year or greater (if former smoker, less than 10 pack years total smoking history).
Exclusion Criteria
* Subject has 3 or more hospitalizations for exacerbations of asthma in the previous year; OR a history of life-threatening asthma, defined by past intubations for asthma, or ICU admission for asthma within the prior 24 months.
* Subject has a history of recurrent lower respiratory tract infections requiring antibiotics (more than 3 in the past 12 months).
* Subject has a history of recurrent oral steroid use for asthma (4 or more pulses of oral steroids in the past 12 months).
* Subject has a known sensitivity to medications required to perform bronchoscopy (such as lidocaine, atropine and benzodiazepines).
* Subject has known systemic hypersensitivity or contraindication to Methacholine chloride or other parasympathomimetic agents.
* Subject has other medical criteria.
18 Years
65 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Narinder S Shargill, PhD
Role: STUDY_DIRECTOR
Asthmatx, Inc.
Locations
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Pulmonary Associates, PA
Phoenix, Arizona, United States
University of Southern California, Adult Asthma and Allergy Center
Los Angeles, California, United States
National Jewish Medical and Research Center
Denver, Colorado, United States
University of Chicago
Chicago, Illinois, United States
Peoria Pulmonary Associates, Ltd.
Peoria, Illinois, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Veritas Clinical Specialties
Topeka, Kansas, United States
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States
Brigham and Womens's Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Henry Ford Medical Center
Detroit, Michigan, United States
HealthPartners Specialty Center, Lung and Sleep Health
Saint Paul, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Saint Vincent Catholic Medical Center
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Hospital of the University of Pennyslvania
Philadelphia, Pennsylvania, United States
Clinical Research Solutions, PC - Baptist Hospitals of East Tennesse
Knoxville, Tennessee, United States
Baylor College of Medicine
Houston, Texas, United States
Virginia Hospital Center
Arlington, Virginia, United States
Swedish Medical Center
Seattle, Washington, United States
University of Wisconsin Hospital
Madison, Wisconsin, United States
John Hunter Hospital
New Lambton Heights, New South Wales, Australia
Sir Charles Gairdner Hospital
Perth, Western Australia, Australia
Royal Adelaide Hospital
Adelaide, , Australia
Hospital Sao Lucas da PUCRS
Porto Alegre, Rio Grande do Sul, Brazil
Irmandade Santa Casa de Miscericordia de Porto Alegre
Porto Alegre, , Brazil
Hospital Universitario Clementino Fraga Filho
Rio de Janeiro, , Brazil
Faculdade da Medicina do ABC
São Paulo, , Brazil
Firestone Institute of Respiratory Health, St. Joseph's Healthcare
Hamilton, Ontario, Canada
Montreal Chest Institute, McGill University
Montreal, Quebec, Canada
Hopital Laval, Centre de Pneumologie
Sainte-Foy, Quebec, Canada
Odense Universitets Hospital, University of Odense
Odense, , Denmark
Universitair Medisch Centrum
Groningen, , Netherlands
Gartnavel General Hospital, University of Glasgow
Glasgow, Scotland, United Kingdom
Birmingham Heartlands Hospital
Birmingham, , United Kingdom
Glenfield General Hospital, Univ. Hospitals of Leicester
Leicester, , United Kingdom
Chelsea & Westminster Healthcare NHS Trust
London, , United Kingdom
Northwest Lung Research Center, Univ. of Manchester
Manchester, , United Kingdom
Countries
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References
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Pavord ID, Thomson NC, Niven RM, Corris PA, Chung KF, Cox G, Armstrong B, Shargill NS, Laviolette M; Research in Severe Asthma Trial Study Group. Safety of bronchial thermoplasty in patients with severe refractory asthma. Ann Allergy Asthma Immunol. 2013 Nov;111(5):402-7. doi: 10.1016/j.anai.2013.05.002. Epub 2013 Jun 13.
Wechsler ME, Laviolette M, Rubin AS, Fiterman J, Lapa e Silva JR, Shah PL, Fiss E, Olivenstein R, Thomson NC, Niven RM, Pavord ID, Simoff M, Hales JB, McEvoy C, Slebos DJ, Holmes M, Phillips MJ, Erzurum SC, Hanania NA, Sumino K, Kraft M, Cox G, Sterman DH, Hogarth K, Kline JN, Mansur AH, Louie BE, Leeds WM, Barbers RG, Austin JH, Shargill NS, Quiring J, Armstrong B, Castro M; Asthma Intervention Research 2 Trial Study Group. Bronchial thermoplasty: Long-term safety and effectiveness in patients with severe persistent asthma. J Allergy Clin Immunol. 2013 Dec;132(6):1295-302. doi: 10.1016/j.jaci.2013.08.009. Epub 2013 Aug 30.
Castro M, Rubin AS, Laviolette M, Fiterman J, De Andrade Lima M, Shah PL, Fiss E, Olivenstein R, Thomson NC, Niven RM, Pavord ID, Simoff M, Duhamel DR, McEvoy C, Barbers R, Ten Hacken NH, Wechsler ME, Holmes M, Phillips MJ, Erzurum S, Lunn W, Israel E, Jarjour N, Kraft M, Shargill NS, Quiring J, Berry SM, Cox G; AIR2 Trial Study Group. Effectiveness and safety of bronchial thermoplasty in the treatment of severe asthma: a multicenter, randomized, double-blind, sham-controlled clinical trial. Am J Respir Crit Care Med. 2010 Jan 15;181(2):116-24. doi: 10.1164/rccm.200903-0354OC. Epub 2009 Oct 8.
Castro M, Rubin A, Laviolette M, Hanania NA, Armstrong B, Cox G; AIR2 Trial Study Group. Persistence of effectiveness of bronchial thermoplasty in patients with severe asthma. Ann Allergy Asthma Immunol. 2011 Jul;107(1):65-70. doi: 10.1016/j.anai.2011.03.005. Epub 2011 Apr 14.
Related Links
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The AIR2 Extension Study (PAS1) contains the Year 2 to Year 5 Study Results.
Other Identifiers
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04-02
Identifier Type: -
Identifier Source: org_study_id
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