Ignite Creation Date:
2025-12-24 @ 3:45 PM
Ignite Modification Date:
2026-01-02 @ 11:01 AM
Study NCT ID:
NCT03243292
Status:
COMPLETED
Last Update Posted:
2020-07-13
First Post:
2017-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bronchial Thermoplasty 10+ Year Study
Sponsor:
Boston Scientific Corporation
Organization:
Study Overview
Official Title:
Ten Year Follow-up of Subjects From 3 Landmark Randomized Controlled Bronchial Thermoplasty (BT) Studies
Status:
COMPLETED
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: