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NCT03478683 · ClinicalTrials.gov registry record · Phase 4
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)
A Phase 4 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 4
- Development phase
- 729
- Enrollment target
NCT03478683: Completed Phase 4 study, sponsored by GlaxoSmithKline.
NCT03478683 is a Phase 4 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 729 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (41% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03478683, a Phase 4 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 729 participants
- Enrollment target
Study Summary
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.
Primary Outcome
FEV1 is an important measure of pulmonary function and is the maximum amount of air that can be forced out in one second after taking a deep breath. FEV1 was measured using spirometry. Serial FEV1 assessments were performed at multiple time points (-30 and -5 minutes pre-dose, and 5 minutes, 15 minutes, 30 minutes, 1 hour, 3 hours, 6 hours, 12 hours, 15 hours, 21 hours, 23 hours and 24 hours post-dose) over 24-hour period at Week 12. Weighted mean change from Baseline at week 12 was calculated b
Interventions
- DRUG FF/UMEC/VI
- DRUG budesonide/formoterol
- DRUG tiotropium
- DRUG albuterol/salbutamol
- DRUG Placebo to match budesonide/formoterol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 729 participants |
| Start Date | 2018-06-25 |
| Est. Completion | 2019-03-14 |
| Phase | Phase 4 |
What the finished NCT03478683 record still lists
NCT03478683 is an interventional study that assigns participants to a tested intervention. The registered 729 participants enrollment target is mid-sized for trials with a published cap, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (41% higher).
The record links to 0 conditions, and to 5 interventions - of which FF/UMEC/VI is the first listed.
NCT03478683 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03478683 about?
NCT03478683 is a clinical study titled "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)". 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...
What is the current status of trial NCT03478683?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 729 participants. The study started on 2018-06-25. Estimated completion is 2019-03-14.
What interventions are being tested in trial NCT03478683?
The interventions under investigation include: FF/UMEC/VI (DRUG), budesonide/formoterol (DRUG), tiotropium (DRUG), albuterol/salbutamol (DRUG), Placebo to match budesonide/formoterol (DRUG).
Who is sponsoring clinical trial NCT03478683?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03478683's enrollment target sits among peer trials
729 114th of 2000 higher than 1,887 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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