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NCT01817764 · ClinicalTrials.gov registry record · Phase 3
A Study to Compare the Efficacy and Safety of Umeclidinium/Vilanterol and Fluticasone Propionate/Salmeterol in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 707
- Enrollment target
NCT01817764 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 707 participants.
The verdict
NCT01817764, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 707 participants
- Enrollment target
Study Summary
This is a multicenter, randomized, double-blind, double-dummy, parallel group study. The purpose of this study is to compare the efficacy and safety of umeclidinium/vilanterol (UMEC/VI) and fluticasone propionate/salmeterol (FSC) in subjects with COPD. Subjects who meet the eligibility criteria at Screening will complete a 7 to 14 day Run-in period. At the end of the run-in period, approximately 710 eligible subjects will be equally randomized (to complete at least 568 evaluable subjects) to one of the 2 treatment groups for 12 weeks: 1. UMEC/VI 62.5/25 micrograms (mcg) administered as one inhalation once-daily in the morning via the Novel dry powder inhaler (NDPI) + placebo administered as one inhalation each morning and evening via single multidose powdered inhaler (ACCUHALER/DISKUS) or 2. FSC 250/50 mcg administered as one inhalation each morning and evening via ACCUHALER/DISKUS + placebo administered once-daily in the morning via NDPI. A safety Follow-up assessment will be conducted approximately 7 days after the end of the study treatment (Early Withdrawal, if applicable). The total duration of subject participation will be approximately 15 weeks.
Interventions
- DRUG Placebo
- DRUG Fluticasone propionate/salmeterol
- DRUG Umeclidinium/vilanterol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 707 participants |
| Start Date | 2013-03-01 |
| Est. Completion | 2013-10-25 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01817764
The ClinicalTrials.gov registry entry for NCT01817764 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 707 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 is the first listed.
NCT01817764 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01817764 about?
NCT01817764 is a clinical study titled "A Study to Compare the Efficacy and Safety of Umeclidinium/Vilanterol and Fluticasone Propionate/Salmeterol in Subjects With Chronic Obstructive Pulmonary Disease (COPD)". This is a multicenter, randomized, double-blind, double-dummy, parallel group study. The purpose of this study is to compare the efficacy and safety of umeclidinium/vilanterol (UMEC/VI) and fluticasone propionate/salmeterol (FSC) in subjects with COPD. Subjects who meet the eligibility criteria at S...
What is the current status of trial NCT01817764?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 707 participants. The study started on 2013-03-01. Estimated completion is 2013-10-25.
What interventions are being tested in trial NCT01817764?
The interventions under investigation include: Placebo (DRUG), Fluticasone propionate/salmeterol (DRUG), Umeclidinium/vilanterol (DRUG).
Who is sponsoring clinical trial NCT01817764?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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