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NCT01313676 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate the Effect of Fluticasone Furoate/Vilanterol on Survival in Subjects With Chronic Obstructive Pulmonary Disease
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 16,568
- Enrollment target
NCT01313676: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT01313676 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 16,568 participants, above the 771-participant average among 15,282 other Phase 3 trials with a reported enrollment target (2049% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01313676, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 16,568 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if fluticasone furoate/vilanterol improves survival in patients with chronic obstructive pulmonary disease with a history of or increased risk of heart disease.
Primary Outcome
Death from any cause: which occurred from the day of starting IP until the Commone End Date (CED). Common End Date (CED) is the study end date that was pre determined where approximately 1000 deaths would have occurred in the Intent-toTreat Efficacy (ITT-E) Population. Only deaths which occurred on or before the CED were used for the primary analysis. Those who had not died by CED, but who were known to be alive on or after the CED, were censored at the CED. Cox Proportional Hazards (PH) Model w
Interventions
- OTHER Placebo
- DRUG fluticasone furoate
- DRUG fluticasone furoate/vilanterol
- DRUG vilanterol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16,568 participants |
| Start Date | 2011-01-25 |
| Est. Completion | 2015-07-15 |
| Phase | Phase 3 |
What the finished NCT01313676 record still lists
NCT01313676 is an interventional study that assigns participants to a tested intervention. Its 16,568 participants enrollment target places it among the larger protocols in the corpus, above the 771-participant average among 15,282 other Phase 3 trials with a reported enrollment target (2049% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01313676 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01313676 about?
NCT01313676 is a clinical study titled "Study to Evaluate the Effect of Fluticasone Furoate/Vilanterol on Survival in Subjects With Chronic Obstructive Pulmonary Disease". The purpose of this study is to determine if fluticasone furoate/vilanterol improves survival in patients with chronic obstructive pulmonary disease with a history of or increased risk of heart disease.
What is the current status of trial NCT01313676?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 16,568 participants. The study started on 2011-01-25. Estimated completion is 2015-07-15.
What interventions are being tested in trial NCT01313676?
The interventions under investigation include: Placebo (OTHER), fluticasone furoate (DRUG), fluticasone furoate/vilanterol (DRUG), vilanterol (DRUG).
Who is sponsoring clinical trial NCT01313676?
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 NCT01313676's enrollment target sits among peer trials
16,568 12th of 2000 higher than 1,989 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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