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NCT01777334 · ClinicalTrials.gov registry record · Phase 3
The Purpose of This Study is to Evaluate the Spirometric Effect (Trough FEV1) of Umeclidinium/Vilanterol 62.5/25 mcg Once Daily Compared With Tiotriopium 18 mcg Once Daily Over a 24-week Treatment Period in Subjects With COPD
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 905
- Enrollment target
NCT01777334: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT01777334 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 905 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (17% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01777334, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 905 participants
- Enrollment target
Study Summary
The purpose of this 24 week study is to evaluate the spirometric lung function effect (trough FEV1) of Umeclidinium/Vilanterol 62.5/25 once daily compared to Tiotropium 18 mcg once daily along with safety assessments in subjects with COPD.
Primary Outcome
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 measurements were taken electronically by spirometry on Days 2, 28, 56, 84, 112, 140, 168, and 169. Baseline is defined as the mean of the assessments made 30 minutes (min) pre-dose and 5 min pre-dose on Treatment Day 1. Trough FEV1 is defined as the mean of the FEV1 values obtained at 23 and 24 hours (hr) after the previous morning's dosing (ie., trough FEV1 o
Interventions
- DRUG Tiotropium 18 mcg
- DRUG Umeclidinium/Vilanterol 62.5/25 mcg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 905 participants |
| Start Date | 2013-01-23 |
| Est. Completion | 2013-09-24 |
| Phase | Phase 3 |
What the finished NCT01777334 record still lists
NCT01777334 is an interventional study that assigns participants to a tested intervention. The registered 905 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (17% higher).
The record links to 0 conditions, and to 2 interventions - of which Tiotropium 18 mcg is the first listed.
NCT01777334 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01777334 about?
NCT01777334 is a clinical study titled "The Purpose of This Study is to Evaluate the Spirometric Effect (Trough FEV1) of Umeclidinium/Vilanterol 62.5/25 mcg Once Daily Compared With Tiotriopium 18 mcg Once Daily Over a 24-week Treatment Period in Subjects With COPD". The purpose of this 24 week study is to evaluate the spirometric lung function effect (trough FEV1) of Umeclidinium/Vilanterol 62.5/25 once daily compared to Tiotropium 18 mcg once daily along with safety assessments in subjects with COPD.
What is the current status of trial NCT01777334?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 905 participants. The study started on 2013-01-23. Estimated completion is 2013-09-24.
What interventions are being tested in trial NCT01777334?
The interventions under investigation include: Tiotropium 18 mcg (DRUG), Umeclidinium/Vilanterol 62.5/25 mcg (DRUG).
Who is sponsoring clinical trial NCT01777334?
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 NCT01777334's enrollment target sits among peer trials
905 347th of 2000 higher than 1,653 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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