NCT00231114

Asthma Intervention Research 2 (AIR2) Trial

Safety and Effectiveness of the Alair® System for the Treatment of Asthma: A Multicenter Randomized Clinical Trial(Asthma Intervention Research (AIR2) Trial)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 297 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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 2:1 (two Alair Group Subjects for every one Control Group Subject).

Conditions

• Asthma

Interventions

Type	Name	Description
DEVICE	Alair System	Treatment of airways with the Alair System
DEVICE	Alair System	Sham treatment of airways with the Alair System

Timeline

• Start date: 2005-09-01
• Primary completion: 2008-08-01
• Completion: 2013-04-01
• First posted: 2005-10-04
• Last updated: 2017-07-27
• Results posted: 2010-11-29

Locations

39 sites across 7 countries: United States, Australia, Brazil, Canada, Denmark, Netherlands, United Kingdom