NCT03243292

Bronchial Thermoplasty 10+ Year Study

Ten Year Follow-up of Subjects From 3 Landmark Randomized Controlled Bronchial Thermoplasty (BT) Studies

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 192 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Asthma

Interventions

Type	Name	Description
OTHER	Bronchial Thermoplasty	patients had radio frequency ablation of the smooth muscle for asthma

Timeline

• Start date: 2017-12-11
• Primary completion: 2019-01-10
• Completion: 2019-01-10
• First posted: 2017-08-08
• Last updated: 2020-07-13

Locations

17 sites across 5 countries: United States, Brazil, Canada, Netherlands, United Kingdom