NCT03478683

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 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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 729 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pulmonary Disease, Chronic Obstructive

Interventions

Type	Name	Description
DRUG	budesonide/formoterol	Subjects will be administered two inhalations of budesonide/formoterol via MDI twice daily
DRUG	albuterol/salbutamol	Subjects will be provided short-acting albuterol/salbutamol as-rescue medication to be used on an as-needed basis throughout the study.
DRUG	FF/UMEC/VI	Subjects will receive FF/UMEC/VI 100/62.5/25 mcg via ELLIPTA once daily in the morning
DRUG	Placebo to match budesonide/formoterol	Subjects will be administered two inhalations of matching placebo twice daily via MDI
DRUG	tiotropium	Subjects will receive tiotropium (18 mcg) once daily in the morning via HandiHaler device
DRUG	Placebo to match FF/UMEC/VI	Matching placebo to FF/UMEC/VI will be administered via ELLIPTA once daily in the morning.
DRUG	placebo to match tiotropium	Subjects will receive tiotropium matching placebo via Handihaler once daily in the morning
DEVICE	ELLIPTA	Subjects will receive FF/UMEC/VI 100/62.5/25 mcg and matching placebo via ELLIPTA in the treatment period. Budesonide/formoterol plus tiotropium once daily plus placebo will be administered via ELLIPTA during the run-in period.
DEVICE	MDI	Subjects will receive budesonide/formoterol and placebo to match budesonide/formoterol via MDI in the treatment period.
DEVICE	HandiHaler	Subjects will be administered tiotropium (18 mcg) or placebo to match tiotropium via HandiHaler during the treatment period.

Timeline

• Start date: 2018-06-25
• Primary completion: 2019-03-14
• Completion: 2019-03-14
• First posted: 2018-03-27
• Last updated: 2020-10-28
• Results posted: 2020-02-12

Locations

57 sites across 4 countries: United States, Czechia, Germany, Netherlands

Regulatory

• FDA-regulated drug study
• FDA-regulated device study