Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
192 participants
OBSERVATIONAL
2017-12-11
2019-01-10
Brief Summary
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Detailed Description
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Compare baseline HRCT scans from subjects from the AIR2 study that enroll in BT 10+ study to examine if there are any clinically significant post-treatment respiratory changes following BT defined as bronchiectasis or bronchial stenosis.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Treated
Subjects that received Bronchial Thermoplasty in a prior study (AIR, RISA, or AIR2)
Bronchial Thermoplasty
patients had radio frequency ablation of the smooth muscle for asthma
Control
Subjects that participated in prior study (AIR) or (RISA) but did not receive Bronchial Thermoplasty Treatment. Determine if the Control group of subjects asthma has progressed any different from those subjects treated with BT.
Bronchial Thermoplasty
patients had radio frequency ablation of the smooth muscle for asthma
Sham
Subjects that participated in the AIR2 study, were blinded and did not receive the treatment. Determine if the Sham group of subjects asthma has progressed any different from those subjects treated with BT.
Bronchial Thermoplasty
patients had radio frequency ablation of the smooth muscle for asthma
Interventions
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Bronchial Thermoplasty
patients had radio frequency ablation of the smooth muscle for asthma
Eligibility Criteria
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Inclusion Criteria
* Subjects who received active BT treatment and had last BT treatment at least 10 years and 6 weeks prior to enrollment
* Control/Sham subjects with at least 10 years of long-term follow-up from index date plus 6 weeks
* Subject is able to read, understand and sign a written Informed Consent to participate in the Study and able to comply with the study requirements
Exclusion Criteria
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Thomas Bowman, MD
Role: STUDY_DIRECTOR
Medical Director, Boston Scientific
Locations
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University of Southern California
Los Angeles, California, United States
Henry Ford Health System
Detroit, Michigan, United States
Regions Hospital Health Partners Specialty Center
Saint Paul, Minnesota, United States
Washington University Medical Center
St Louis, Missouri, United States
Cleveland Clinic
Cleveland, Ohio, United States
Pulmonary Associates of Northern Virginia
Arlington, Virginia, United States
Imandade Santa Casa de Misercordia
Pôrto Alegre, Rio Grande do Sul, Brazil
Faculdade da Medicina do ABC
Santo André, São Paulo, Brazil
Gente Clube de Vida Promoção E Serviços 9 Centro de Pesquisa Maimônides
Pôrto Alegre, , Brazil
Instituto de Doenças do Tórax /Universidade Federal do Rio de Janeiro/UFRJ
Rio de Janeiro, , Brazil
Montreal Chest Institute
Montreal, Quebec, Canada
Institute Universitaire de Cardiologie et Pneumologie de Quebec
Québec, Quebec, Canada
Universitair Medisch Centrum Groningen
Groningen, , Netherlands
Chelsea and Westminster Hospital
Chelsea, London, United Kingdom
Gartnavel General Hospital
Glasgow, Scotland, United Kingdom
University of Leicester Glenfield Hospital
Leicester, , United Kingdom
Wythenshawe Hospital, University of Manchester
Manchester, , United Kingdom
Countries
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References
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Chaudhuri R, Rubin A, Sumino K, Lapa E Silva JR, Niven R, Siddiqui S, Klooster K, McEvoy C, Shah PL, Simoff M, Khatri S, Barbers R, Mark Grubb G, McMullen EA, Olson JL, Laviolette M; BT10+ Study Group. Safety and effectiveness of bronchial thermoplasty after 10 years in patients with persistent asthma (BT10+): a follow-up of three randomised controlled trials. Lancet Respir Med. 2021 May;9(5):457-466. doi: 10.1016/S2213-2600(20)30408-2. Epub 2021 Jan 29.
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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92115848
Identifier Type: -
Identifier Source: org_study_id
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