Status:
COMPLETED
Asthma Intervention Research 2 (AIR2) Trial
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Asthma
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 sy...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
297 Patients enrolled
Trial Details
Trial ID
NCT00231114
Start Date
September 1 2005
End Date
April 1 2013
Last Update
July 27 2017
Active Locations (39)
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1
Pulmonary Associates, PA
Phoenix, Arizona, United States, 85020
2
University of Southern California, Adult Asthma and Allergy Center
Los Angeles, California, United States, 90033
3
National Jewish Medical and Research Center
Denver, Colorado, United States, 80206
4
University of Chicago
Chicago, Illinois, United States, 60637