Asthma Intervention Research 2 (AIR2) Trial

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 Beta-agonists.

Official Title

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

Conditions

Asthma

Study Type

Interventional

Study Design

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Further Details

Primary Outcome Measures:

The difference between Study groups in the change in Asthma Quality of Life Questionnaire (AQLQ) score from Baseline and follow-up visits.

Secondary Outcome Measures:

Percent of Symptom Free Days, Symptom scores, Morning PEF, ACQ score,Number of puffs of rescue medication used, Percent Days rescue medication was used, FEV1

Study Start

September 2005

Eligibility & Criteria

Ages Eligible for Study: 18 Years – 65 Years
Genders Eligible for Study: Both

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 Beta-agonist (LABA).
Subject has a Pre-bronchodilator 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.
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.