Asthma Intervention Research 2 (AIR2) Trial
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This page only displays public information reproduced from the official ClinicalTrials.gov record NCT00231114. It adds no medical advice, opinions, or eligibility judgments. The official record remains the source of truth for eligibility criteria, enrollment, and contact information.
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Official title
Safety and Effectiveness of the Alair® System for the Treatment of Asthma: A Multicenter Randomized Clinical Trial(Asthma Intervention Research (AIR2) Trial)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT00231114
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 297 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 2005 (Type not available)
- Primary completion
- Aug 2008 (Actual)
- Completion
- Apr 2013 (Actual)
- Last update posted
- Jul 27, 2017
2005 – 2013
United States locations
- U.S. sites
- 22
- U.S. states
- 20
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pulmonary Associates, PA | Phoenix | Arizona | 85020 | — |
| University of Southern California, Adult Asthma and Allergy Center | Los Angeles | California | 90033 | — |
| National Jewish Medical and Research Center | Denver | Colorado | 80206 | — |
| University of Chicago | Chicago | Illinois | 60637 | — |
| Peoria Pulmonary Associates, Ltd. | Peoria | Illinois | 61603 | — |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | — |
| Veritas Clinical Specialties | Topeka | Kansas | 66606 | — |
| Johns Hopkins University School of Medicine | Baltimore | Maryland | 21205 | — |
| Brigham and Womens's Hospital | Boston | Massachusetts | 02115 | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | — |
| Henry Ford Medical Center | Detroit | Michigan | 48202 | — |
| HealthPartners Specialty Center, Lung and Sleep Health | Saint Paul | Minnesota | 55101 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110-1093 | — |
| Saint Vincent Catholic Medical Center | New York | New York | 10011 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| Hospital of the University of Pennyslvania | Philadelphia | Pennsylvania | 19104 | — |
| Clinical Research Solutions, PC - Baptist Hospitals of East Tennesse | Knoxville | Tennessee | 37920 | — |
| Baylor College of Medicine | Houston | Texas | 77030 | — |
| Virginia Hospital Center | Arlington | Virginia | 22205-3698 | — |
| Swedish Medical Center | Seattle | Washington | 98104 | — |
| University of Wisconsin Hospital | Madison | Wisconsin | 53792 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 17 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00231114, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 27, 2017 · Synced Nov 14, 2026
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