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NCT01336608 · ClinicalTrials.gov registry record · Phase 3
A 24-week Arterial Stiffness Study With Fluticasone Furoate/Vilanterol in COPD
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 446
- Enrollment target
NCT01336608: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT01336608 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 446 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01336608, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 446 participants
- Enrollment target
Study Summary
The purpose of the study is to investigate the effect of fluticasone furoate/vilanterol Inhalation Powder on arterial stiffness compared with placebo and vilanterol over a 24-week treatment period in subjects with COPD and aortic pulse wave velocity of 11.0 m/s or above.
Primary Outcome
PWV is defined as the speed of travel of the pressure pulse along an arterial segment and can be obtained for any arterial segment accessible to palpation. aPWV is measured with tonometers positioned transcutaneously at the base of the common carotid artery and over the femoral artery. PWV increases with arterial stiffness and is defined by the Moens-Korteweg equation: PWV=square root of (Eh/2ρR), where E is Young's modulus of the arterial wall, h is the wall thickness, R is the arterial radius
Interventions
- DRUG Placebo
- DRUG Fluticasone Furoate/Vilanterol
- DRUG Vilanterol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 446 participants |
| Start Date | 2011-03-04 |
| Est. Completion | 2014-11-04 |
| Phase | Phase 3 |
What the finished NCT01336608 record still lists
NCT01336608 is an interventional study that assigns participants to a tested intervention. The registered 446 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (42% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01336608 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01336608 about?
NCT01336608 is a clinical study titled "A 24-week Arterial Stiffness Study With Fluticasone Furoate/Vilanterol in COPD". The purpose of the study is to investigate the effect of fluticasone furoate/vilanterol Inhalation Powder on arterial stiffness compared with placebo and vilanterol over a 24-week treatment period in subjects with COPD and aortic pulse wave velocity of 11.0 m/s or above.
What is the current status of trial NCT01336608?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 446 participants. The study started on 2011-03-04. Estimated completion is 2014-11-04.
What interventions are being tested in trial NCT01336608?
The interventions under investigation include: Placebo (DRUG), Fluticasone Furoate/Vilanterol (DRUG), Vilanterol (DRUG).
Who is sponsoring clinical trial NCT01336608?
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 NCT01336608's enrollment target sits among peer trials
446 864th of 2000 higher than 1,137 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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