A Randomized Study, Comparing Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) Single Inhaler Triple Therapy, Versus Multiple Inhaler Therapy (Budesonide/Formoterol Plus Tiotropium) in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Public ClinicalTrials.gov record NCT03478683. 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 Phase IV, 12-week, Randomised, Double-blind, Triple Dummy Study to Compare Single Inhaler Triple Therapy, Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) With Multiple Inhaler Therapy (Budesonide/Formoterol Plus Tiotropium) Based on Lung Function and Symptoms in Participants With Chronic Obstructive Pulmonary Disease
Study identification
- NCT ID
- NCT03478683
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Lead sponsor
- GlaxoSmithKline
- Industry
- Enrollment
- 729 participants
Conditions and interventions
Conditions
Interventions
- budesonide/formoterol Drug
- albuterol/salbutamol Drug
- FF/UMEC/VI Drug
- Placebo to match budesonide/formoterol Drug
- tiotropium Drug
- Placebo to match FF/UMEC/VI Drug
- placebo to match tiotropium Drug
- ELLIPTA Device
- MDI Device
- HandiHaler Device
Drug · Device
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 24, 2018
- Primary completion
- Mar 13, 2019
- Completion
- Mar 13, 2019
- Last update posted
- Oct 27, 2020
2018 – 2019
United States locations
- U.S. sites
- 40
- U.S. states
- 13
- U.S. cities
- 34
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Gold River | California | 95670 | — |
| GSK Investigational Site | Clearwater | Florida | 33756 | — |
| GSK Investigational Site | Clearwater | Florida | 33765 | — |
| GSK Investigational Site | DeBary | Florida | 32713 | — |
| GSK Investigational Site | Edgewater | Florida | 32132 | — |
| GSK Investigational Site | Miami | Florida | 33135 | — |
| GSK Investigational Site | Miami | Florida | 33144 | — |
| GSK Investigational Site | Miami | Florida | 33165 | — |
| GSK Investigational Site | Miami | Florida | 33186 | — |
| GSK Investigational Site | Ocala | Florida | 34470 | — |
| GSK Investigational Site | Ocala | Florida | 34474 | — |
| GSK Investigational Site | Port Charlotte | Florida | 33952 | — |
| GSK Investigational Site | Port Orange | Florida | 32127 | — |
| GSK Investigational Site | Peachtree Corners | Georgia | 30071 | — |
| GSK Investigational Site | Flint | Michigan | 48503 | — |
| GSK Investigational Site | Fridley | Minnesota | 55432 | — |
| GSK Investigational Site | Woodbury | Minnesota | 55125 | — |
| GSK Investigational Site | Albuquerque | New Mexico | 87108 | — |
| GSK Investigational Site | The Bronx | New York | 10455 | — |
| GSK Investigational Site | Asheville | North Carolina | 28801 | — |
| GSK Investigational Site | Raleigh | North Carolina | 27607 | — |
| GSK Investigational Site | Shelby | North Carolina | 28150 | — |
| GSK Investigational Site | Columbus | Ohio | 43213 | — |
| GSK Investigational Site | Columbus | Ohio | 43215 | — |
| GSK Investigational Site | Dayton | Ohio | 45417 | — |
| GSK Investigational Site | Tulsa | Oklahoma | 74136 | — |
| GSK Investigational Site | Portland | Oregon | 97202 | — |
| GSK Investigational Site | Anderson | South Carolina | 29621 | — |
| GSK Investigational Site | Columbia | South Carolina | 29204 | — |
| GSK Investigational Site | Easley | South Carolina | 29640 | — |
| GSK Investigational Site | Fort Mill | South Carolina | 29707 | — |
| 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 | Spartanburg | South Carolina | 29303 | — |
| GSK Investigational Site | Baytown | Texas | 77521 | — |
| GSK Investigational Site | Cypress | Texas | 77429 | — |
| GSK Investigational Site | Houston | Texas | 77058 | — |
| GSK Investigational Site | Tomball | Texas | 77375 | — |
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 17 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03478683, 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 Oct 27, 2020 · Synced Jul 23, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03478683 live on ClinicalTrials.gov.