Status:
COMPLETED
Bronchial Thermoplasty 10+ Year Study
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Asthma
Eligibility:
All Genders
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, control...
Detailed Description
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 mon...
Eligibility Criteria
Inclusion
- 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
- 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.
Exclusion
Key Trial Info
Start Date :
December 11 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 10 2019
Estimated Enrollment :
192 Patients enrolled
Trial Details
Trial ID
NCT03243292
Start Date
December 11 2017
End Date
January 10 2019
Last Update
July 13 2020
Active Locations (17)
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1
University of Southern California
Los Angeles, California, United States, 90033
2
Henry Ford Health System
Detroit, Michigan, United States, 48202-268
3
Regions Hospital Health Partners Specialty Center
Saint Paul, Minnesota, United States, 55130
4
Washington University Medical Center
St Louis, Missouri, United States, 63110-1093