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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 is a NA study that has completed, run by Boston Scientific Corporation. The registered enrollment target is 297 participants.
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).
Interventions
- DEVICE Alair System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 297 participants |
| Start Date | 2005-09 |
| Est. Completion | 2013-04 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00231114
The ClinicalTrials.gov registry entry for NCT00231114 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 297 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Scientific Corporation, which has 280 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Alair System is the first listed.
NCT00231114 reports 0 study locations.
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.
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