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NCT01899742 · ClinicalTrials.gov registry record · Phase 3
The Purpose of the This Study is to Evaluate the Spirometric Effect (Trough FEV1) of Umeclidinium/Vilanterol 62.5/25 mcg Once Daily Compared With Tiotropium 18mcg Once Daily Over a a 12-week Treatment Period in Subjects With COPD Who Continue to Have Symptoms on Tiotropium
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 497
- Enrollment target
NCT01899742: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT01899742 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 497 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (36% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01899742, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 497 participants
- Enrollment target
Study Summary
The primary objective is to compare the efficacy of UMEC/VI Inhalation Powder (62.5/25 mcg) once-daily with tiotropium (18 mcg) once-daily over 12 weeks for the treatment of subjects with COPD who have received tiotropium and continue to have symptoms while on tiotropium.
Primary Outcome
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in 1 second. BL was the mean of the values measured 23 hour and 24 hour after dosing prior to Day 1 (ie. after the last open label \[OL\] tiotropium dosing and prior to the randomized dose). Change from BL is defined as the post-BL value minus the BL value. Trough FEV1 on Day 85 is defined as the mean of the FEV1 values obtained at 23 and 24 hours after dosing on Day 84 (at Week 12 + 1 d
Interventions
- DRUG Tiotropium 18 mcg
- DRUG Umeclidinium/Vilanterol 62.5/25 mcg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 497 participants |
| Start Date | 2014-09-15 |
| Est. Completion | 2015-07-22 |
| Phase | Phase 3 |
What the finished NCT01899742 record still lists
NCT01899742 is an interventional study that assigns participants to a tested intervention. The registered 497 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 (36% lower).
The record links to 0 conditions, and to 2 interventions - of which Tiotropium 18 mcg is the first listed.
NCT01899742 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01899742 about?
NCT01899742 is a clinical study titled "The Purpose of the This Study is to Evaluate the Spirometric Effect (Trough FEV1) of Umeclidinium/Vilanterol 62.5/25 mcg Once Daily Compared With Tiotropium 18mcg Once Daily Over a a 12-week Treatment Period in Subjects With COPD Who Continue to Have Symptoms on Tiotropium". The primary objective is to compare the efficacy of UMEC/VI Inhalation Powder (62.5/25 mcg) once-daily with tiotropium (18 mcg) once-daily over 12 weeks for the treatment of subjects with COPD who have received tiotropium and continue to have symptoms while on tiotropium.
What is the current status of trial NCT01899742?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 497 participants. The study started on 2014-09-15. Estimated completion is 2015-07-22.
What interventions are being tested in trial NCT01899742?
The interventions under investigation include: Tiotropium 18 mcg (DRUG), Umeclidinium/Vilanterol 62.5/25 mcg (DRUG).
Who is sponsoring clinical trial NCT01899742?
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 NCT01899742's enrollment target sits among peer trials
497 775th of 2000 higher than 1,225 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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