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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary purpose of this study is to evaluate lung function and health related quality of life (HRQoL) after 84 days of treatment with a single inhaler triple therapy combination of FF/UMEC/VI \[100/62.5/25 microgram (mcg)\] once daily via the ELLIPTA™ compared with a multiple inhaler combination therapy of Symbicort Metered Dose Inhaler (MDI) (budesonide/formoterol 320/9 mcg) twice daily plus Spiriva HandiHaler (tiotropium 18 mcg) once daily. The study will inform healthcare providers that subjects can be effectively and safely switched to FF/UMEC/VI single inhaler therapy from a multiple inhaler triple therapy regimen of Symbicort MDI and Spiriva Handihaler. Eligible subjects will enter a 4-week run-in period during which they will be administered budesonide/formoterol (320/9 mcg) twice daily plus tiotropium (18 mcg) once daily plus placebo via ELLIPTA. Following the run-in period, subjects will be randomized to receive one of the following study treatments for 84 days: 1) FF/UMEC/VI 100/62.5/25 mcg via ELLIPTA once daily in the morning plus two inhalations of placebo to match budesonide/formoterol via MDI, twice daily plus placebo to match tiotropium via HandiHaler once daily in the morning or 2) Budesonide/formoterol 320/9 mcg via MDI, twice daily plus tiotropium 18 mcg via HandiHaler once daily in the morning plus placebo via ELLIPTA once daily in the morning. Subjects will then enter a one week follow-up period. The total duration for a subject in the study will be approximately 17 weeks. ELLIPTA is a registered trademark of the GlaxoSmithKline group of companies.
Study identification
- NCT ID
- NCT03478683
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- 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 Sep 9, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03478683 live on ClinicalTrials.gov.