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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 is a Phase 4 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 198 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02275052
The ClinicalTrials.gov registry entry for NCT02275052 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 198 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo DPI is the first listed.
NCT02275052 reports 0 study locations.
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.
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