Bronchial Thermoplasty 10+ Year Study
Ten Year Follow-up of Subjects From 3 Landmark Randomized Controlled Bronchial Thermoplasty (BT) Studies
1 other identifier
observational
192
5 countries
17
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2017
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 20, 2017
CompletedFirst Posted
Study publicly available on registry
August 8, 2017
CompletedStudy Start
First participant enrolled
December 11, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 10, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 10, 2019
CompletedJuly 13, 2020
July 1, 2020
1.1 years
July 20, 2017
July 9, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Primary Safety Endpoint: Absence of clinically significant post-treatment respiratory changes from Baseline (pre-Bronchial Thermoplasty) CT.
Following BT, defined as bronchiectasis or bronchial stenosis, as confirmed by Pulmonary Volumetric HRCT scan at the BT 10+study visit in those3 subjects who had baseline Volumetric HRCT scan in the AIR2 study. Baseline and 10+ year HRCTs are to be read by an independent radiologist and also assessed by an independent pulmonologist.
The BT 10+ study's single visit must occur 10 years after the subject's last BT procedure.
Primary Effectiveness: Endpoints at 10 or more years following the subjects' last BT procedure; Asthma Exacerbations, ER Visits, Hospitalizations, and respiratory Serious Adverse Events.
Durability of the treatment effect by comparing the proportion of subjects who experience severe asthma exacerbations during the first and fifth years after BT treatment with the proportion of subjects who experience severe asthma exacerbations during the 12 month period prior to the BT 10+ study visit.
The BT 10+ study's single visit must occur 10 years after the subject's last BT procedure.
Secondary Outcomes (9)
Severe asthma exacerbation rates exacerbations
One day visit
Severe asthma exacerbation rates subject
One day visit
Severe asthma exacerbation rates year
One day visit
rates of emergency room visits for respiratory adverse events
One day visit
proportion of subjects with emergency room visits for respiratory adverse events
One day visit
- +4 more secondary outcomes
Study Arms (3)
Treated
Subjects that received Bronchial Thermoplasty in a prior study (AIR, RISA, or AIR2)
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.
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.
Interventions
patients had radio frequency ablation of the smooth muscle for asthma
Eligibility Criteria
Subjects that participated in one one or more of the prior studies (AIR, RISA, or AIR2) will be invited to participate in this study.
You may qualify if:
- Subjects previously enrolled in AIR, RISA or AIR2
- 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
You may not qualify if:
- Severe asthma exacerbation or chest infection in the past 4 weeks. Subject entry into this study should be delayed until free from severe asthma exacerbation or chest infection for a minimum of 4 weeks.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
University of Southern California
Los Angeles, California, 90033, United States
Henry Ford Health System
Detroit, Michigan, 48202-268, United States
Regions Hospital Health Partners Specialty Center
Saint Paul, Minnesota, 55130, United States
Washington University Medical Center
St Louis, Missouri, 63110-1093, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Pulmonary Associates of Northern Virginia
Arlington, Virginia, 22205, United States
Imandade Santa Casa de Misercordia
Pôrto Alegre, Rio Grande do Sul, 90035074, Brazil
Faculdade da Medicina do ABC
Santo André, São Paulo, 09060-650, Brazil
Gente Clube de Vida Promoção E Serviços 9 Centro de Pesquisa Maimônides
Pôrto Alegre, 90480-000, Brazil
Instituto de Doenças do Tórax /Universidade Federal do Rio de Janeiro/UFRJ
Rio de Janeiro, 21949-900, Brazil
Montreal Chest Institute
Montreal, Quebec, H4A 3J1, Canada
Institute Universitaire de Cardiologie et Pneumologie de Quebec
Québec, Quebec, G1V4G5, Canada
Universitair Medisch Centrum Groningen
Groningen, 9713 GZ, Netherlands
Chelsea and Westminster Hospital
Chelsea, London, SW10 9NH, United Kingdom
Gartnavel General Hospital
Glasgow, Scotland, G12 OYN, United Kingdom
University of Leicester Glenfield Hospital
Leicester, LE5 4PW, United Kingdom
Wythenshawe Hospital, University of Manchester
Manchester, M23 9LT, United Kingdom
Related Publications (1)
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.
PMID: 33524320DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Thomas Bowman, MD
Medical Director, Boston Scientific
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2017
First Posted
August 8, 2017
Study Start
December 11, 2017
Primary Completion
January 10, 2019
Study Completion
January 10, 2019
Last Updated
July 13, 2020
Record last verified: 2020-07