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Ten Year Follow-up of Subjects From 3 Landmark Randomized Controlled Bronchial Thermoplasty (BT) Studies
To confirm the long-term efficacy and safety of Bronchial Thermoplasty (BT) at 10 years follow-up or beyond in subjects previously enrolled in any of the following Boston Scientific-sponsored, controlled pre-approval studies: AIR, RISA and AIR2.
Compare rates of severe asthma exacerbations of subjects during the first and fifth year after BT treatment with the proportion of subjects who experience severe asthma exacerbations during the 12 months period prior to enrollment. 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.
Age
All ages
Sex
ALL
Healthy Volunteers
No
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
Start Date
December 11, 2017
Primary Completion Date
January 10, 2019
Completion Date
January 10, 2019
Last Updated
July 13, 2020
192
ACTUAL participants
Bronchial Thermoplasty
OTHER
Lead Sponsor
Boston Scientific Corporation
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07219173