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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)

NCT03478683 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 729

Last updated 2020-10-28

Study results available
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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

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.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-25
Primary Completion
2019-03-14
Completion
2019-03-14
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States
  • Czechia
  • Germany
  • Netherlands

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03478683 on ClinicalTrials.gov