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NCT03034915 · ClinicalTrials.gov registry record · Phase 4
A 24-week Study to Compare Umeclidinium/Vilanterol (UMEC/VI), UMEC and Salmeterol in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
A Phase 4 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 4
- Development phase
- 2,696
- Enrollment target
NCT03034915 is a Phase 4 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 2,696 participants.
The verdict
NCT03034915, a Phase 4 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 2,696 participants
- Enrollment target
Study Summary
COPD is characterized by an airflow limitation, which is not fully reversible, usually progressive and accompanied by chronic cough, sputum production and dyspnea, which can be a major cause of disability and anxiety associated with the disease. In addition, COPD is associated with poor health-related quality of life (HRQoL). Pharmacologic therapy is used to improve lung function, reduce symptoms, reduce the frequency and severity of exacerbations, and also to improve health status and exercise tolerance. This is a multi-center, randomized, double blind, double dummy, 3-arm parallel group study to compare umeclidinium/vilanterol (62.5/25 microgram \[mcg\], once daily), umeclidinium (62.5 mcg, once daily), and salmeterol (50 mg, twice daily) in male and female subjects with COPD. The primary purpose of this study is to demonstrate improvements in lung function for subjects treated with UMEC/VI compared with UMEC for 24 weeks. Approximately 2424 subjects will be randomized across 3 parallel arms in 1:1:1 ratio. Subjects will be stratified based on long-acting bronchodilator usage during the run-in period (none, one or 2 long-acting bronchodilators per day). Subjects will receive either UMEC/VI inhalation powder (62.5/25 microgram \[mcg\] once daily) administered via the ELLIPTA® dry powder inhaler (DPI) and placebo twice daily via DISKUS® DPI; or UMEC (62.5 mcg once daily) administered via the ELLIPTA DPI and placebo twice daily via DISKUS DPI or salmeterol (50 mcg twice daily \[BID\]) administered via the DISKUS DPI and placebo once daily via ELLIPTA DPI. The duration of the study will be 29 to 31 weeks including a pre-screening period of 2 weeks, run-in period of 4 weeks, treatment period of 24 weeks and follow-up period of 1 week. ELLIPTA and DISKUS are trademarks of GSK group of companies.
Interventions
- DRUG UMEC/VI 62.5/25 mcg via ELLIPTA
- DRUG UMEC 62.5 mcg via ELLIPTA
- DRUG Salmeterol 50 mcg via DISKUS
- DRUG Placebo via ELLIPTA
- DRUG Placebo via DISKUS
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,696 participants |
| Start Date | 2017-06-16 |
| Est. Completion | 2018-06-18 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03034915
The ClinicalTrials.gov registry entry for NCT03034915 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 2,696 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 5 interventions - of which UMEC/VI 62.5/25 mcg via ELLIPTA is the first listed.
NCT03034915 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03034915 about?
NCT03034915 is a clinical study titled "A 24-week Study to Compare Umeclidinium/Vilanterol (UMEC/VI), UMEC and Salmeterol in Subjects With Chronic Obstructive Pulmonary Disease (COPD)". COPD is characterized by an airflow limitation, which is not fully reversible, usually progressive and accompanied by chronic cough, sputum production and dyspnea, which can be a major cause of disability and anxiety associated with the disease. In addition, COPD is associated with poor health-relat...
What is the current status of trial NCT03034915?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 2,696 participants. The study started on 2017-06-16. Estimated completion is 2018-06-18.
What interventions are being tested in trial NCT03034915?
The interventions under investigation include: UMEC/VI 62.5/25 mcg via ELLIPTA (DRUG), UMEC 62.5 mcg via ELLIPTA (DRUG), Salmeterol 50 mcg via DISKUS (DRUG), Placebo via ELLIPTA (DRUG), Placebo via DISKUS (DRUG).
Who is sponsoring clinical trial NCT03034915?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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