A Comparative Study Between Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) Single Inhaler Triple Therapy Versus Tiotropium Monotherapy in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Public ClinicalTrials.gov record NCT03474081. 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, Double-dummy Study to Compare Single Inhaler Triple Therapy, Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI), With Tiotropium Monotherapy 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.
COPD is a progressive disease characterized by increasing obstruction to airflow and the progressive development of respiratory symptoms including chronic cough, increased sputum production, dyspnea and wheezing. Once-daily triple therapy of an Inhaled Corticosteroid/ Long-acting Muscarinic Receptor Antagonists/ Long Acting Beta-Agonist (ICS/LAMA/LABA) that is combination of FF/UMEC/VI in a single device is being developed with the aim of providing a new treatment option for the management of advanced COPD. 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 once daily via the ELLIPTA® dry powder inhaler (DPI) compared with tiotropium once daily via HANDIHALER®, in subjects with COPD. Subjects will be randomized 1:1 to receive FF/UMEC/VI or tiotropium in the morning for 84 days. Subjects will also receive albuterol/salbutamol as a rescue therapy throughout the study. Approximately 848 subjects with advanced COPD will be enrolled in the study. The total study duration will be approximately 17 weeks including, 4-week run-in period, 12-week treatment period and a 1-week follow-up period. ELLIPTA is a registered trademark of GlaxoSmithKline (GSK) group of companies. HANDIHALER and RESPIMAT are registered trademarks of Boeringher Ingelheim.
Study identification
- NCT ID
- NCT03474081
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 800 participants
Conditions and interventions
Conditions
Interventions
- FF/UMEC/VI Drug
- Tiotropium Drug
- Albuterol/salbutamol Drug
- Placebo to match FF/UMEC/VI Drug
- Placebo to match tiotropium Drug
- ELLIPTA inhaler Device
- HANDIHALER Device
- MDI 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
- Mar 29, 2018 (Actual)
- Primary completion
- Jul 17, 2019 (Actual)
- Completion
- Jul 17, 2019 (Actual)
- Last update posted
- Jul 15, 2021
2018 – 2019
United States locations
- U.S. sites
- 33
- U.S. states
- 14
- U.S. cities
- 32
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Andalusia | Alabama | 36420 | — |
| GSK Investigational Site | Huntington Beach | California | 92647 | — |
| GSK Investigational Site | Sacramento | California | 95821 | — |
| GSK Investigational Site | Simi Valley | California | 93065 | — |
| GSK Investigational Site | Colorado Springs | Colorado | 80907 | — |
| GSK Investigational Site | Daytona Beach | Florida | 32117 | — |
| GSK Investigational Site | Kissimmee | Florida | 34741 | — |
| GSK Investigational Site | Miami | Florida | 33126 | — |
| GSK Investigational Site | Miami | Florida | 33134 | — |
| GSK Investigational Site | Miami Lakes | Florida | 33014 | — |
| GSK Investigational Site | Orlando | Florida | 32825 | — |
| GSK Investigational Site | Ormond Beach | Florida | 32174 | — |
| GSK Investigational Site | Panama City | Florida | 32405 | — |
| GSK Investigational Site | Nampa | Idaho | 83687 | — |
| GSK Investigational Site | Oxon Hill | Maryland | 20745 | — |
| GSK Investigational Site | Edina | Minnesota | 55435 | — |
| GSK Investigational Site | Minneapolis | Minnesota | 55407 | — |
| GSK Investigational Site | Bronxville | New York | 10708 | — |
| GSK Investigational Site | Fayetteville | New York | 13066 | — |
| GSK Investigational Site | Gastonia | North Carolina | 28054 | — |
| GSK Investigational Site | Cincinnati | Ohio | 45242 | — |
| GSK Investigational Site | Dublin | Ohio | 43016 | — |
| GSK Investigational Site | DuBois | Pennsylvania | 15801 | — |
| GSK Investigational Site | Anderson | South Carolina | 29621 | — |
| GSK Investigational Site | Gaffney | South Carolina | 29340 | — |
| GSK Investigational Site | Greer | South Carolina | 29650 | — |
| GSK Investigational Site | Little River | South Carolina | 029566 | — |
| GSK Investigational Site | Pelzer | South Carolina | 29669 | — |
| GSK Investigational Site | Seneca | South Carolina | 29678 | — |
| GSK Investigational Site | Spartanburg | South Carolina | 29303 | — |
| GSK Investigational Site | Corsicana | Texas | 75110 | — |
| GSK Investigational Site | Huntsville | Texas | 77340 | — |
| GSK Investigational Site | Salt Lake City | Utah | 84102 | — |
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 39 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03474081, 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 Jul 15, 2021 · Synced Oct 16, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03474081 live on ClinicalTrials.gov.