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NCT01086384 · ClinicalTrials.gov registry record · Phase 3
Asthma Exacerbation Study
A Phase 3 study of Asthma, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 2,020
- Enrollment target
- 20
- Study locations
NCT01086384: Completed Phase 3 study of Asthma, sponsored by GlaxoSmithKline.
NCT01086384 is a Phase 3 study of Asthma that has completed, run by GlaxoSmithKline. The registered enrollment target is 2,020 participants, above the 1,558-participant average among 374 other Asthma trials with a reported enrollment target (30% higher). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01086384, a Phase 3 study of Asthma, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,020 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will establish the safety as well as demonstrate benefit of the addition of a LABA to an ICS by utilizing an endpoint (time to first severe asthma exacerbation) that informs on both safety and efficacy.
Primary Outcome
Asthma is a medical condition that causes narrowing of the small airways in the lungs. A severe asthma exacerbation is defined as a deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids. Only events deemed by the adjudication committee to be severe asthma exacerbations were used in the analysis of severe asthma
Conditions Studied
Interventions
- DRUG Fluticasone Furoate/GW642444
- DRUG Fluticasone furoate
Study Locations (20)
California
- GSK Investigational Site - Bell Gardens
- GSK Investigational Site - Fresno
- GSK Investigational Site - Huntington Beach
- GSK Investigational Site - Long Beach
- GSK Investigational Site - Los Angeles
- GSK Investigational Site - Mission Viejo
- GSK Investigational Site - Napa
- GSK Investigational Site - Rancho Mirage
- GSK Investigational Site - Riverside
- GSK Investigational Site - Rolling Hills Estates
- GSK Investigational Site - Roseville
- GSK Investigational Site - San Diego
- GSK Investigational Site - Stockton
- GSK Investigational Site - Torrance
Alabama
- GSK Investigational Site - Birmingham
- GSK Investigational Site - Mobile
- GSK Investigational Site - Oxford
Arizona
- GSK Investigational Site - Phoenix
- GSK Investigational Site - Scottsdale
- GSK Investigational Site - Tucson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,020 participants |
| Start Date | 2010-02-22 |
| Est. Completion | 2011-09-15 |
| Phase | Phase 3 |
What the finished NCT01086384 record still lists
NCT01086384 is an interventional study that assigns participants to a tested intervention. Its 2,020 participants enrollment target places it among the larger protocols in the corpus, above the 1,558-participant average among 374 other Asthma trials with a reported enrollment target (30% higher).
The record links to 1 condition, with Asthma appearing as the primary indexed condition, and to 2 interventions - of which Fluticasone Furoate/GW642444 is the first listed.
NCT01086384 names 20 study sites across 3 states, led by California, Alabama, Arizona.
Frequently Asked Questions
What is clinical trial NCT01086384 about?
NCT01086384 is a clinical study titled "Asthma Exacerbation Study". This study will establish the safety as well as demonstrate benefit of the addition of a LABA to an ICS by utilizing an endpoint (time to first severe asthma exacerbation) that informs on both safety and efficacy.
What is the current status of trial NCT01086384?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,020 participants. The study started on 2010-02-22. Estimated completion is 2011-09-15.
What conditions does trial NCT01086384 study?
This clinical trial studies the following conditions: Asthma.
What interventions are being tested in trial NCT01086384?
The interventions under investigation include: Fluticasone Furoate/GW642444 (DRUG), Fluticasone furoate (DRUG).
Who is sponsoring clinical trial NCT01086384?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01086384 being conducted?
This trial has 20 study locations across Alabama, Arizona, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Asthma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01086384's enrollment target sits among peer trials
2,020 23rd of 374 higher than 352 of 374 other Asthma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Asthma 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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