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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
Ten Year Follow-up of Subjects From 3 Landmark Randomized Controlled Bronchial Thermoplasty (BT) Studies
Secondary ID [1] 0 0
92115848
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Primary Safety Endpoint: Absence of clinically significant post-treatment respiratory changes from Baseline (pre-Bronchial Thermoplasty) CT.
Timepoint [1] 0 0
The BT 10+ study's single visit must occur 10 years after the subject's last BT procedure.
Primary outcome [2] 0 0
Primary Effectiveness: Endpoints at 10 or more years following the subjects' last BT procedure; Asthma Exacerbations, ER Visits, Hospitalizations, and respiratory Serious Adverse Events.
Timepoint [2] 0 0
The BT 10+ study's single visit must occur 10 years after the subject's last BT procedure.
Secondary outcome [1] 0 0
Severe asthma exacerbation rates exacerbations
Timepoint [1] 0 0
One day visit
Secondary outcome [2] 0 0
Severe asthma exacerbation rates subject
Timepoint [2] 0 0
One day visit
Secondary outcome [3] 0 0
Severe asthma exacerbation rates year
Timepoint [3] 0 0
One day visit
Secondary outcome [4] 0 0
rates of emergency room visits for respiratory adverse events
Timepoint [4] 0 0
One day visit
Secondary outcome [5] 0 0
proportion of subjects with emergency room visits for respiratory adverse events
Timepoint [5] 0 0
One day visit
Secondary outcome [6] 0 0
Rates of hospitalizations for respiratory adverse events
Timepoint [6] 0 0
One day visit
Secondary outcome [7] 0 0
Proportion of subjects with hospitalizations for respiratory adverse events
Timepoint [7] 0 0
One day visit
Secondary outcome [8] 0 0
Rates of Respiratory Serious Adverse Events (SAEs)
Timepoint [8] 0 0
One day visit
Secondary outcome [9] 0 0
Proportion of subjects with respiratory SAEs)
Timepoint [9] 0 0
One day visit

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
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/12/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
10/01/2019
Sample size
Target
Accrual to date
Final
192
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Michigan
Country [3] 0 0
United States of America
State/province [3] 0 0
Minnesota
Country [4] 0 0
United States of America
State/province [4] 0 0
Missouri
Country [5] 0 0
United States of America
State/province [5] 0 0
Ohio
Country [6] 0 0
United States of America
State/province [6] 0 0
Virginia
Country [7] 0 0
Brazil
State/province [7] 0 0
RS
Country [8] 0 0
Brazil
State/province [8] 0 0
Sao Paulo
Country [9] 0 0
Brazil
State/province [9] 0 0
Pôrto Alegre
Country [10] 0 0
Brazil
State/province [10] 0 0
Rio De Janeiro
Country [11] 0 0
Canada
State/province [11] 0 0
Quebec
Country [12] 0 0
Netherlands
State/province [12] 0 0
Groningen
Country [13] 0 0
United Kingdom
State/province [13] 0 0
London
Country [14] 0 0
United Kingdom
State/province [14] 0 0
Scotland
Country [15] 0 0
United Kingdom
State/province [15] 0 0
Leicester
Country [16] 0 0
United Kingdom
State/province [16] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boston Scientific Corporation
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT03243292
Trial related presentations / publications
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

Contacts
Principal investigator
Name 0 0
Thomas Bowman, MD
Address 0 0
Medical Director, Boston Scientific
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03243292