Trials / Completed
CompletedNCT01350336
Bronchial Thermoplasty in Severe Persistent Asthma
Post-FDA Approval Clinical Trial Evaluating Bronchial Thermoplasty in Severe Persistent Asthma
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 284 (actual)
- Sponsor
- Boston Scientific Corporation · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
As Conditions of Approval of the PMA for the Alair System, the FDA requires Boston Scientific to generate data to assess the durability of the BT treatment effect as well as safety data in the intended use population in the United States.
Detailed description
This is a multicenter, open-label, single arm study designed to demonstrate durability of the treatment effect and to evaluate the short-term and longer-term safety profile of the Alair System in the United States in the intended use population (patients 18 years and older with severe persistent asthma).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Alair System | Treatment of airways with the Alair System |
Timeline
- Start date
- 2011-04-07
- Primary completion
- 2019-11-12
- Completion
- 2020-03-17
- First posted
- 2011-05-09
- Last updated
- 2021-03-05
- Results posted
- 2021-03-05
Locations
27 sites across 2 countries: United States, Canada
Source: ClinicalTrials.gov record NCT01350336. Inclusion in this directory is not an endorsement.