Study:
Safety and Effectiveness of the Alair® System for the Treatment of Asthma: A Multicenter Randomized Clinical Trial(Asthma Intervention Research (AIR2) Trial)
Rationale:
n/a
Purpose:
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 ß2-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 ß2-agonists (LABA).
A Bayesian adaptive approach to sample size selection is used with a randomization scheme of
2:1 (two Alair Group Subjects for every one Control Group Subject).
Study Status: Active, not recruiting
Recruiting:
n/a
| Condition |
Intervention |
Phase |
|
Asthma |
Device: Alair System
Device: Alair System |
N/A |
Verified by
Asthmatx, Inc.
July, 2012
Sponsored by: Asthmatx, Inc.
Information provided by: Asthmatx, Inc.
ClinicalTrials.gov identifier: NCT00231114
Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Cleveland Clinic Foundation
Cleveland, Ohio 44195
United States
Narinder S Shargill, PhD., Study Director