Asthma Intervention Research 2 (AIR2) Trial

Boston Scientific

Status

Completed

Conditions

Asthma

Treatments

Device: Alair System

Study type

Interventional

Funder types

Industry

Identifiers

NCT00231114

04-02

Details and patient eligibility

About

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).

Enrollment

297 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subject is an adult between the ages of 18 to 65 years.
Subject has asthma and is taking regular maintenance medication that includes Inhaled corticosteroid (ICS) AND long acting ß2-agonist (LABA).
Subject has a Pre-bronchodilator Forced Expiratory Volume in one second (FEV1) of greater than or equal to 60% of predicted after medication stabilization during the Baseline Period.
Subject has a PC20 < 8 mg/ml per methacholine inhalation test using standardized methods. PC20 is a provocative concentration of Provocholine® (a brand of methacholine chloride) resulting in a drop of FEV1 of 20% or more from Baseline.
Subject has at least two days of asthma symptoms during the 4-weeks of the Baseline Diary Period.
Subject is a non-smoker for 1 year or greater (if former smoker, less than 10 pack years total smoking history).

Exclusion criteria

Subject has a Post-bronchodilator FEV1 of less than 65%.
Subject has 3 or more hospitalizations for exacerbations of asthma in the previous year; OR a history of life-threatening asthma, defined by past intubations for asthma, or ICU admission for asthma within the prior 24 months.
Subject has a history of recurrent lower respiratory tract infections requiring antibiotics (more than 3 in the past 12 months).
Subject has a history of recurrent oral steroid use for asthma (4 or more pulses of oral steroids in the past 12 months).
Subject has a known sensitivity to medications required to perform bronchoscopy (such as lidocaine, atropine and benzodiazepines).
Subject has known systemic hypersensitivity or contraindication to Methacholine chloride or other parasympathomimetic agents.
Subject has other medical criteria.