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NCT01054885 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety Study of Fluticasone Furoate (FF)/GW642444 Inhalation Powder and the Individual Components in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,226
- Enrollment target
NCT01054885: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT01054885 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 1,226 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (59% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01054885, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,226 participants
- Enrollment target
Study Summary
The Purpose of this study is to assess the efficacy and safety of two strengths of the FF/GW642444 Inhalation Powder in subject with Chronic Obstructive Pulmonary Disease (COPD)
Primary Outcome
Co-Primary Endpoint: Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. Serial FEV1 measurements were taken electronically by spirometry at BL, weeks 2, 8, 12, and 84 (Day 168). Weighted mean (WM) was calculated using the 0 - 4 h post-dose FEV1 measurements that included the pre-dose (Day 1: 30 minutes \[min\] and 5 min prior to dosing; other serial visits:23 and 24 h
Interventions
- DRUG Placebo
- DRUG FF Inhalation Powder
- DRUG FF/GW642444 Inhalation Powder
- DRUG GW642444 Inhalation Powder
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,226 participants |
| Start Date | 2009-10-19 |
| Est. Completion | 2011-02-08 |
| Phase | Phase 3 |
What the finished NCT01054885 record still lists
NCT01054885 is an interventional study that assigns participants to a tested intervention. Its 1,226 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (59% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01054885 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01054885 about?
NCT01054885 is a clinical study titled "Efficacy and Safety Study of Fluticasone Furoate (FF)/GW642444 Inhalation Powder and the Individual Components in Subjects With Chronic Obstructive Pulmonary Disease (COPD)". The Purpose of this study is to assess the efficacy and safety of two strengths of the FF/GW642444 Inhalation Powder in subject with Chronic Obstructive Pulmonary Disease (COPD)
What is the current status of trial NCT01054885?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,226 participants. The study started on 2009-10-19. Estimated completion is 2011-02-08.
What interventions are being tested in trial NCT01054885?
The interventions under investigation include: Placebo (DRUG), FF Inhalation Powder (DRUG), FF/GW642444 Inhalation Powder (DRUG), GW642444 Inhalation Powder (DRUG).
Who is sponsoring clinical trial NCT01054885?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01054885's enrollment target sits among peer trials
1,226 214th of 2000 higher than 1,787 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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