N/A
N=297
Asthma Intervention Research 2 (AIR2) Trial
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT00231114 ↗Enrolled (actual)
297
Serious AEs
7.9%
Results posted
Nov 2010
Primary outcome: Primary: Integrated Asthma Quality of Life Questionnaire (AQLQ) Score (Change From Baseline) — 1.35; 1.16 Units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Alair System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boston Scientific Corporation
- Primary completion
- Aug 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Integrated Asthma Quality of Life Questionnaire (AQLQ) Score (Change From Baseline) |
1.35; 1.16 | — |
| SECONDARY Percent Symptom-Free Days (Change From Baseline) |
24.4; 21.0 | — |
| SECONDARY Total Symptom Score (Change From Baseline) |
-1.7; -1.6 | — |
| SECONDARY Number of Puffs of Rescue Medication Used (Change From Baseline) |
-6.0; -4.3 | — |
| SECONDARY Percent Days Rescue Medication Used (Change From Baseline) |
-24.0; -22.0 | — |
| SECONDARY Asthma Control Questionnaire (ACQ) Score (Change From Baseline) |
-0.82; -0.77 | — |
| SECONDARY Morning Peak Expiratory Flow (amPEF) (Change From Baseline) |
27.8; 22.3 | — |
| SECONDARY Pre-Bronchodilator FEV1 (Percent Predicted) (Change From Baseline) |
-1.4; -0.1 | — |
| SECONDARY Post-Bronchodilator FEV1 (Percent Predicted) (Change From Baseline) |
-2.8; -2.4 | — |
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).
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00231114). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.