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NCT00231114 · ClinicalTrials.gov registry record · NA
Asthma Intervention Research 2 (AIR2) Trial
A NA study, sponsored by Boston Scientific Corporation.
- Completed
- Registry status
- NA
- Development phase
- 297
- Enrollment target
NCT00231114: Completed NA study, sponsored by Boston Scientific Corporation.
NCT00231114 is a NA study that has completed, run by Boston Scientific Corporation. The registered enrollment target is 297 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00231114, a NA study, has completed, sponsored by Boston Scientific Corporation.
- COMPLETED
- Registry status
- NA
- Development phase
- 297 participants
- Enrollment target
Study 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).
Primary Outcome
Change between Baseline and the average of 6-, 9-, and 12-month Follow-Up Visits. The AQLQ consists of 32 questions (scale from 1 to 7, where 7 reflects a higher quality of life). An increase in the AQLQ score indicates a better quality of life. The average of the 6-, 9-, and 12-month differences in the AQLQ Score are referred to as the "Integrated AQLQ Score."
Interventions
- DEVICE Alair System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 297 participants |
| Start Date | 2005-09 |
| Est. Completion | 2013-04 |
| Phase | NA |
What the finished NCT00231114 record still lists
NCT00231114 is an interventional study that assigns participants to a tested intervention. The registered 297 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (79% lower).
The record links to 0 conditions, and to 1 intervention - of which Alair System is the first listed.
NCT00231114 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00231114 about?
NCT00231114 is a clinical study titled "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...
What is the current status of trial NCT00231114?
This trial is currently completed. It is a NA study. The enrollment target is 297 participants. The study started on 2005-09. Estimated completion is 2013-04.
What interventions are being tested in trial NCT00231114?
The interventions under investigation include: Alair System (DEVICE).
Who is sponsoring clinical trial NCT00231114?
This trial is sponsored by Boston Scientific Corporation, which has 280 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00231114's enrollment target sits among peer trials
297 372nd of 2000 higher than 1,628 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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