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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03243292
Registration number
NCT03243292
Ethics application status
Date submitted
20/07/2017
Date registered
8/08/2017
Date last updated
13/07/2020
Titles & IDs
Public title
Bronchial Thermoplasty 10+ Year Study
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Scientific title
Ten Year Follow-up of Subjects From 3 Landmark Randomized Controlled Bronchial Thermoplasty (BT) Studies
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Secondary ID [1]
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92115848
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Asthma
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Condition category
Condition code
Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Other interventions - Bronchial Thermoplasty
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.
Other interventions: Bronchial Thermoplasty
patients had radio frequency ablation of the smooth muscle for asthma
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Primary Safety Endpoint: Absence of clinically significant post-treatment respiratory changes from Baseline (pre-Bronchial Thermoplasty) CT.
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Assessment method [1]
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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.
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Timepoint [1]
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The BT 10+ study's single visit must occur 10 years after the subject's last BT procedure.
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Primary outcome [2]
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Primary Effectiveness: Endpoints at 10 or more years following the subjects' last BT procedure; Asthma Exacerbations, ER Visits, Hospitalizations, and respiratory Serious Adverse Events.
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Assessment method [2]
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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.
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Timepoint [2]
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The BT 10+ study's single visit must occur 10 years after the subject's last BT procedure.
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Secondary outcome [1]
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Severe asthma exacerbation rates exacerbations
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Assessment method [1]
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evaluated for the 12 month period prior to the BT 10+ study visit and will be compared to the first and fifth years after BT treatment:
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Timepoint [1]
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One day visit
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Secondary outcome [2]
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Severe asthma exacerbation rates subject
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Assessment method [2]
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evaluated for the 12 month period prior to the BT 10+ study visit and will be compared to the first and fifth years after BT treatment:
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Timepoint [2]
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One day visit
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Secondary outcome [3]
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Severe asthma exacerbation rates year
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Assessment method [3]
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evaluated for the 12 month period prior to the BT 10+ study visit and will be compared to the first and fifth years after BT treatment:
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Timepoint [3]
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One day visit
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Secondary outcome [4]
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rates of emergency room visits for respiratory adverse events
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Assessment method [4]
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evaluated for the 12 month period prior to the BT 10+ study visit and will be compared to the first and fifth years after BT treatment:
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Timepoint [4]
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One day visit
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Secondary outcome [5]
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proportion of subjects with emergency room visits for respiratory adverse events
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Assessment method [5]
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evaluated for the 12 month period prior to the BT 10+ study visit and will be compared to the first and fifth years after BT treatment:
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Timepoint [5]
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One day visit
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Secondary outcome [6]
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Rates of hospitalizations for respiratory adverse events
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Assessment method [6]
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evaluated for the 12 month period prior to the BT 10+ study visit and will be compared to the first and fifth years after BT treatment:
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Timepoint [6]
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One day visit
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Secondary outcome [7]
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Proportion of subjects with hospitalizations for respiratory adverse events
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Assessment method [7]
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evaluated for the 12 month period prior to the BT 10+ study visit and will be compared to the first and fifth years after BT treatment:
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Timepoint [7]
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One day visit
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Secondary outcome [8]
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Rates of Respiratory Serious Adverse Events (SAEs)
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Assessment method [8]
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evaluated for the 12 month period prior to the BT 10+ study visit and will be compared to the first and fifth years after BT treatment:
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Timepoint [8]
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One day visit
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Secondary outcome [9]
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Proportion of subjects with respiratory SAEs)
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Assessment method [9]
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evaluated for the 12 month period prior to the BT 10+ study visit and will be compared to the first and fifth years after BT treatment:
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Timepoint [9]
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One day visit
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Eligibility
Key inclusion criteria
Inclusion Criteria
- 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
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Minimum age
No limit
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- 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.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
11/12/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
10/01/2019
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Sample size
Target
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Accrual to date
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Final
192
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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United States of America
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California
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United States of America
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Michigan
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United States of America
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Minnesota
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Missouri
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United States of America
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Ohio
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United States of America
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Virginia
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Country [7]
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Brazil
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State/province [7]
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RS
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Country [8]
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Brazil
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State/province [8]
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Sao Paulo
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Brazil
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Pôrto Alegre
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Brazil
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Rio De Janeiro
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Canada
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Quebec
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Netherlands
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Groningen
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United Kingdom
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London
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United Kingdom
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Scotland
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United Kingdom
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Leicester
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United Kingdom
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State/province [16]
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Manchester
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Boston Scientific Corporation
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Address
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03243292
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
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Thomas Bowman, MD
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Address
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Medical Director, Boston Scientific
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Fax
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Email
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03243292
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