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NCT02152605 · ClinicalTrials.gov registry record · Phase 3
A Phase IIIb Study to Evaluate the Efficacy of Umeclidinium/Vilanterol (UMEC/VI) in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 498
- Enrollment target
NCT02152605: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT02152605 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 498 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02152605, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 498 participants
- Enrollment target
Study Summary
This study is a 12-week, multicenter, randomized, double blind, parallel group, placebo-controlled study. The purpose of this study is to replicate the therapeutic benefit of UMEC/VI 62.5/25 microgram (mcg) on health-related quality of life as reflected by St. George's Respiratory Questionnaire (SGRQ) scores and symptoms as reflected by rescue medication use observed in the 6 month placebo controlled study (DB2113373). Lung function will be assessed as it provides an objective measure to support the subjective patient reported outcomes of SGRQ and rescue medication use. The study is intended to provide additional evidence to support the use of UMEC/VI for the maintenance treatment of COPD Approximately 496 subjects will be randomized from approximately 62 centers in order to ensure 422 subjects complete 12 weeks of treatment. Eligible subjects will be randomized to UMEC/VI 62.5/25mcg or placebo in a 1:1 ratio. All treatments will be administered once-daily in the morning via a Dry Powder Inhaler (DPI). There will be a total of 5 clinic visits. The total duration of study participation will be approximately 15 weeks. All subjects will be provided with albuterol/salbutamol to use as needed for the relief of COPD symptoms throughout the run-in and double-blind treatment periods.
Primary Outcome
The SGRQ is a disease-specific questionnaire, self-completed by participants(par), used to evaluate the effect of UMEC/VI on health-related quality of life as compared to placebo in par with COPD. The scores range from 0 (minimum, best possible health status) to 100 (maximum, worst possible health status). The SGRQ contains 76 items grouped into three domains (symptoms, activity and impacts). Analysis was performed using mixed model repeated measures with covariates of Baseline (scores recorded
Interventions
- DRUG Placebo
- DRUG UMEC/VI
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 498 participants |
| Start Date | 2014-09-01 |
| Est. Completion | 2015-03-05 |
| Phase | Phase 3 |
What the finished NCT02152605 record still lists
NCT02152605 is an interventional study that assigns participants to a tested intervention. The registered 498 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 (35% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02152605 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02152605 about?
NCT02152605 is a clinical study titled "A Phase IIIb Study to Evaluate the Efficacy of Umeclidinium/Vilanterol (UMEC/VI) in Subjects With Chronic Obstructive Pulmonary Disease (COPD)". This study is a 12-week, multicenter, randomized, double blind, parallel group, placebo-controlled study. The purpose of this study is to replicate the therapeutic benefit of UMEC/VI 62.5/25 microgram (mcg) on health-related quality of life as reflected by St. George's Respiratory Questionnaire (SG...
What is the current status of trial NCT02152605?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 498 participants. The study started on 2014-09-01. Estimated completion is 2015-03-05.
What interventions are being tested in trial NCT02152605?
The interventions under investigation include: Placebo (DRUG), UMEC/VI (DRUG).
Who is sponsoring clinical trial NCT02152605?
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 NCT02152605's enrollment target sits among peer trials
498 775th of 2000 higher than 1,226 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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