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NCT03478696 · 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
- 732
- Enrollment target
NCT03478696 is a Phase 4 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 732 participants.
The verdict
NCT03478696, a Phase 4 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 732 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 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.
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 | 732 participants |
| Start Date | 2018-06-25 |
| Est. Completion | 2019-03-18 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03478696
The ClinicalTrials.gov registry entry for NCT03478696 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 732 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which FF/UMEC/VI is the first listed.
NCT03478696 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03478696 about?
NCT03478696 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 ELLIPTA® compared with a multiple inhaler combination th...
What is the current status of trial NCT03478696?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 732 participants. The study started on 2018-06-25. Estimated completion is 2019-03-18.
What interventions are being tested in trial NCT03478696?
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 NCT03478696?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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