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NCT02275052 · ClinicalTrials.gov registry record · Phase 4
A Study to Evaluate the Effect of the Combination of Umeclidinium (UMEC) and Vilanterol (VI) on Exercise Endurance Time (EET) in Participants With Chronic Obstructive Pulmonary Disease (COPD)
A Phase 4 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 4
- Development phase
- 198
- Enrollment target
NCT02275052: Completed Phase 4 study, sponsored by GlaxoSmithKline.
NCT02275052 is a Phase 4 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 198 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02275052, a Phase 4 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 198 participants
- Enrollment target
Study Summary
This is a multicenter, randomized, double-blind, placebo-controlled, 2-period, complete block design cross-over study. The purpose of this study is to evaluate the effect of UMEC/VI 62.5/25 microgram (mcg) on EET as measured by the Endurance Shuttle Walk Test (ESWT) compared to placebo. Additionally, the effect of UMEC/VI compared to placebo on lung function and lung volumes in COPD patients will be characterized. Approximately 298 participants will be screened and, assuming 35% of these will not be eligible for randomization; approximately 194 participants will be randomized. Eligible participants will be randomized 1:1 to one of 2 treatment sequences. In sequence 1 participants will receive UMEC/VI 62.5/25 mcg in Treatment Period 1 and placebo in Treatment Period 2. In sequence 2 participants will receive placebo in Treatment Period 1 and UMEC/VI 62.5/25 mcg in Treatment Period 2. Treatments will be delivered once-daily via a dry powder inhaler (DPI). Each treatment period will be for 12 weeks and will be separated by a wash out period of 12-17 days. The total duration of patient participation, including the Follow-Up will be approximately 30 weeks. All participants will be provided with albuterol for use on an "as needed (prn)" basis throughout the run-in, washout and study treatment periods while on investigational product.
Primary Outcome
EET post-dose at W12 is defined as the EET obtained 3 hours after dosing at W12. EET was measured using the externally paced field walking test called endurance shuttle walk test (ESWT). Change from BL in EET at W12 was analyzed using a repeated measures model with covariates of period walking speed, mean walking speed, period, trt, visit (Day 2, W6 and W12), smoking status, visit by period walking speed, visit by mean walking speed and visit by trt interactions. BL was the EET assessment obtain
Interventions
- DRUG Placebo DPI
- DRUG UMEC/VI DPI
- DRUG Albuterol/salbutamol MDI
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 198 participants |
| Start Date | 2015-01-23 |
| Est. Completion | 2016-06-02 |
| Phase | Phase 4 |
What the finished NCT02275052 record still lists
NCT02275052 is an interventional study that assigns participants to a tested intervention. The registered 198 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo DPI is the first listed.
NCT02275052 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02275052 about?
NCT02275052 is a clinical study titled "A Study to Evaluate the Effect of the Combination of Umeclidinium (UMEC) and Vilanterol (VI) on Exercise Endurance Time (EET) in Participants With Chronic Obstructive Pulmonary Disease (COPD)". This is a multicenter, randomized, double-blind, placebo-controlled, 2-period, complete block design cross-over study. The purpose of this study is to evaluate the effect of UMEC/VI 62.5/25 microgram (mcg) on EET as measured by the Endurance Shuttle Walk Test (ESWT) compared to placebo. Additionall...
What is the current status of trial NCT02275052?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 198 participants. The study started on 2015-01-23. Estimated completion is 2016-06-02.
What interventions are being tested in trial NCT02275052?
The interventions under investigation include: Placebo DPI (DRUG), UMEC/VI DPI (DRUG), Albuterol/salbutamol MDI (DRUG).
Who is sponsoring clinical trial NCT02275052?
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 NCT02275052's enrollment target sits among peer trials
198 446th of 2000 higher than 1,553 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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