At a glance
ClinicalIndex Comparison RecordN/ACompleted· 284 enrolled
Drug / intervention
Alair Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Post-FDA Approval Clinical Trial Evaluating Bronchial Thermoplasty in Severe Persistent Asthma
In Brief
A clinical study evaluating Alair System for Severe Asthma. Completed, enrolled 284 participants across 27 sites in 2 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSevere Asthma
CountriesCanada, United States
Collaborators--
Timeline
N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartApr 2011
First PostedMay 2011
Primary CompletionNov 2019
Study CompletionMar 2020
TodayJul 2026
First PostedMay 9, 2011
Enrollment StartApr 7, 2011
Primary CompletionNov 12, 2019
Study CompletionMar 17, 2020
TodayJul 2, 2026
Enrollment to primary: 8.6 yearsPosted 15.1 years ago
Interventions
Alair Systemdevice
Treatment of airways with the Alair System