A 24-week Study to Compare Umeclidinium/Vilanterol (UMEC/VI), UMEC and Salmeterol in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Public ClinicalTrials.gov record NCT03034915. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A 24-week Treatment, Multi-center, Randomized, Double-blind, Double-dummy, Parallel Group Study to Compare Umeclidinium/Vilanterol, Umeclidinium, and Salmeterol in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03034915
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 2,696 participants
Conditions and interventions
Conditions
Interventions
- 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
Drug
Eligibility (public fields only)
- Age range
- 40 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 16, 2017 (Actual)
- Primary completion
- Jun 18, 2018 (Actual)
- Completion
- Jun 18, 2018 (Actual)
- Last update posted
- Mar 11, 2020
2017 – 2018
United States locations
- U.S. sites
- 37
- U.S. states
- 16
- U.S. cities
- 37
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Phoenix | Arizona | 85018 | — |
| GSK Investigational Site | Lincoln | California | 95648 | — |
| GSK Investigational Site | Clearwater | Florida | 33765 | — |
| GSK Investigational Site | Orlando | Florida | 32825 | — |
| GSK Investigational Site | Tampa | Florida | 33603 | — |
| GSK Investigational Site | O'Fallon | Illinois | 62269 | — |
| GSK Investigational Site | Natchitoches | Louisiana | 71457 | — |
| GSK Investigational Site | Edina | Minnesota | 55435 | — |
| GSK Investigational Site | Fridley | Minnesota | 55432 | — |
| GSK Investigational Site | Minneapolis | Minnesota | 55407 | — |
| GSK Investigational Site | Woodbury | Minnesota | 55125 | — |
| GSK Investigational Site | Chesterfield | Missouri | 63017 | — |
| GSK Investigational Site | Saint Charles | Missouri | 63301 | — |
| GSK Investigational Site | St Louis | Missouri | 63141 | — |
| GSK Investigational Site | Omaha | Nebraska | 68134 | — |
| GSK Investigational Site | Albuquerque | New Mexico | 87108 | — |
| GSK Investigational Site | Charlotte | North Carolina | 28207 | — |
| GSK Investigational Site | Gastonia | North Carolina | 28054 | — |
| GSK Investigational Site | Monroe | North Carolina | 28112 | — |
| GSK Investigational Site | Mooresville | North Carolina | 28117 | — |
| GSK Investigational Site | Winston-Salem | North Carolina | 27103 | — |
| GSK Investigational Site | Cincinnati | Ohio | 45231 | — |
| GSK Investigational Site | Medford | Oregon | 97504 | — |
| GSK Investigational Site | Anderson | South Carolina | 29621 | — |
| GSK Investigational Site | Charleston | South Carolina | 29406-7108 | — |
| GSK Investigational Site | Easley | South Carolina | 29640 | — |
| GSK Investigational Site | Gaffney | South Carolina | 29340 | — |
| GSK Investigational Site | Greenville | South Carolina | 29615 | — |
| GSK Investigational Site | Lancaster | South Carolina | 29720 | — |
| GSK Investigational Site | Mt. Pleasant | South Carolina | 29464 | — |
| GSK Investigational Site | Rock Hill | South Carolina | 29732 | — |
| GSK Investigational Site | Seneca | South Carolina | 29678 | — |
| GSK Investigational Site | Spartanburg | South Carolina | 29303 | — |
| GSK Investigational Site | Union | South Carolina | 29379 | — |
| GSK Investigational Site | Sherman | Texas | 75092 | — |
| GSK Investigational Site | Abingdon | Virginia | 24210 | — |
| GSK Investigational Site | Morgantown | West Virginia | 26505 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 175 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03034915, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 11, 2020 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03034915 live on ClinicalTrials.gov.