Asthma Intervention Research 2 (AIR2) Trial

Completed · Not applicable · Has a placebo group

Conditions studied: Asthma

In brief

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).

Key facts

Study ID

NCT00231114

Run by

Boston Scientific Corporation

People needed

297

Starts

2005-09-01

Expected to finish

2013-04-01

Last updated by the study team

2017-07-27

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Pulmonary Associates, PA — Phoenix, Arizona, United States
• University of Southern California, Adult Asthma and Allergy Center — Los Angeles, California, United States
• National Jewish Medical and Research Center — Denver, Colorado, United States
• University of Chicago — Chicago, Illinois, United States
• Peoria Pulmonary Associates, Ltd. — Peoria, Illinois, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• Veritas Clinical Specialties — Topeka, Kansas, United States
• Johns Hopkins University School of Medicine — Baltimore, Maryland, United States
• Brigham and Womens's Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Henry Ford Medical Center — Detroit, Michigan, United States
• HealthPartners Specialty Center, Lung and Sleep Health — Saint Paul, Minnesota, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Saint Vincent Catholic Medical Center — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Hospital of the University of Pennyslvania — Philadelphia, Pennsylvania, United States
• Clinical Research Solutions, PC - Baptist Hospitals of East Tennesse — Knoxville, Tennessee, United States
• Baylor College of Medicine — Houston, Texas, United States
• Virginia Hospital Center — Arlington, Virginia, United States
• Swedish Medical Center — Seattle, Washington, United States
• University of Wisconsin Hospital — Madison, Wisconsin, United States
• John Hunter Hospital — New Lambton Heights, New South Wales, Australia
• Sir Charles Gairdner Hospital — Perth, Western Australia, Australia
• Royal Adelaide Hospital — Adelaide, Australia

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.