Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00231114
Status:
COMPLETED
Last Update Posted:
2017-07-27
First Post:
2005-09-30
Brief Title:
Asthma Intervention Research 2 AIR2 Trial
Sponsor:
Boston Scientific Corporation
Organization:
Boston Scientific Corporation
Study Overview
Official Title:
Safety and Effectiveness of the Alair System for the Treatment of Asthma A Multicenter Randomized Clinical TrialAsthma Intervention Research AIR2 Trial
Status:
COMPLETED
Status Verified Date:
2014-03
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:
The objective of this randomized double blind sham-controlled study is to demonstrate the safety and effectiveness of the Alair System in a population of subjects with severe asthma who are still symptomatic despite being managed on conventional therapy of high doses of inhaled corticosteroids and long-acting β2-agonists
The primary efficacy endpoint will be the difference between Study groups in the change in Asthma Quality of Life Questionnaire AQLQ score from Baseline and the average score from the 6- 9- and 12-month follow-up visits
All other outcome measures assessed at 12 months post-treatment
This will be a multicenter randomized double-blind sham-controlled study comparing the effects of treatment with the Alair System to conventional therapy of inhaled corticosteroids ICS and long-acting β2-agonists LABA
A Bayesian adaptive approach to sample size selection is used with a randomization scheme of 21 two Alair Group Subjects for every one Control Group Subject
The primary efficacy endpoint will be the difference between Study groups in the change in Asthma Quality of Life Questionnaire AQLQ score from Baseline and the average score from the 6- 9- and 12-month follow-up visits
All other outcome measures assessed at 12 months post-treatment
This will be a multicenter randomized double-blind sham-controlled study comparing the effects of treatment with the Alair System to conventional therapy of inhaled corticosteroids ICS and long-acting β2-agonists LABA
A Bayesian adaptive approach to sample size selection is used with a randomization scheme of 21 two Alair Group Subjects for every one Control Group Subject
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None