A Study to Evaluate the Effect of the Combination of Umeclidinium (UMEC) and Vilanterol (VI) on Exercise Endurance Time (EET) in Participants With Chronic Obstructive Pulmonary Disease (COPD)

PHASE4CompletedINTERVENTIONAL
Enrollment

198

Participants

Timeline

Start Date

January 23, 2015

Primary Completion Date

June 2, 2016

Study Completion Date

June 2, 2016

Conditions
Pulmonary Disease, Chronic Obstructive
Interventions
DRUG

UMEC/VI DPI

The DPI will contain a total of 30 doses. Each DPI will be comprised of two double-foil, laminate blister strips. Each blister of one strip will consist of 62.5mcg of UMEC blended with lactose and magnesium stearate while each blister of other strip will consist of 25 mcg of VI blended with lactose and magnesium stearate. Each actuation of the DPI will deliver the contents of one blister from each strip simultaneously

DRUG

Placebo DPI

The placebo DPI, identical in appearance to the inhaler containing active study medication, will have two blister strips, each containing 30 blisters of lactose and magnesium stearate.

DRUG

Albuterol/salbutamol MDI

Albuterol/salbutamol MDI (metered-dose inhaler) or nebules will be permitted throughout the study as rescue medication, for use as-needed. Albuterol/salbutamol will be sourced from local commercial stock or provided centrally from GlaxoSmithKline. Nebules will not be supplied.

Trial Locations (10)

28207

GSK Investigational Site, Charlotte

29303

GSK Investigational Site, Spartanburg

29340

GSK Investigational Site, Gaffney

29379

GSK Investigational Site, Union

29615

GSK Investigational Site, Greenville

29621

GSK Investigational Site, Anderson

29640

GSK Investigational Site, Easley

35501

GSK Investigational Site, Jasper

63301

GSK Investigational Site, Saint Charles

97504

GSK Investigational Site, Medford

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY