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Asthma Intervention Research 2 (AIR2) Trial

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

This information is abridged to display results relevant only to Cleveland Clinic. To see complete record visit ClinicalTrials.gov
  Information obtained from ClinicalTrials.gov on
Link to the current ClinicalTrials.gov record.

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