At a glance
ClinicalIndex Comparison Record- ✓Age 18–65 years
- ✓Asthma on maintenance therapy with both inhaled corticosteroid and long-acting beta-2 agonist
- ✓Pre-bronchodilator FEV1 ≥60% predicted
- ✓Airway hyperresponsiveness: PC20 <8 mg/mL on methacholine challenge
- ✕Post-bronchodilator FEV1 <65%
- ✕≥3 hospitalizations for asthma exacerbations in prior year OR life-threatening asthma (prior intubation or ICU admission within 24 months)
- ✕>3 lower respiratory tract infections requiring antibiotics in past 12 months
- ✕≥4 pulses of oral steroids for asthma in past 12 months
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Safety and Effectiveness of the Alair® System for the Treatment of Asthma: A Multicenter Randomized Clinical Trial(Asthma Intervention Research (AIR2) Trial)
In Brief
A clinical study evaluating Alair System for Asthma. Completed, enrolled 297 participants across 39 sites in 7 countries.
Detailed 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).
Study Details
Timeline
Interventions
Treatment of airways with the Alair System
Sham treatment of airways with the Alair System