NCT01957163 - Study to Compare the Addition of Umeclidinium Bromide (UMEC) to Fluticasone Furoate (FF)/Vilanterol (VI), With Placebo Plus FF/VI in Subjects With Chronic Obstructive Pulmonary Disease (COPD) | Biotech Hunter

Enrollment

619

Participants

Timeline

Start Date

October 1, 2013

Primary Completion Date

April 1, 2014

Study Completion Date

April 1, 2014

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

DRUG

Dry white powder containing 100mcg of Fluticasone Furoate blended with lactose per blister was administered by DPI.

DRUG

Dry white powder containing 25mcg of Vilanterol micronised drug (as the 'M' salt triphenylacetate) blended with lactose and magnesium stearate per blister was administered by DPI.

DRUG

UMEC

Umeclidinium bromide in a powder blend with lactose and magnesium stearate was used at two different doses 62.5mcg and 125mcg.

DRUG

Placebo

The matching placebo DPI identical in appearance to the inhaler containing active study medication.

Trial Locations (53)

4000

GSK Investigational Site, San Miguel de Tucumán

5500

GSK Investigational Site, Mendoza

24210

GSK Investigational Site, Abingdon

26505

GSK Investigational Site, Morgantown

29303

GSK Investigational Site, Spartanburg

29379

GSK Investigational Site, Union

29615

GSK Investigational Site, Greenville

29640

GSK Investigational Site, Easley

33603

GSK Investigational Site, Tampa

35501

GSK Investigational Site, Jasper

63141

GSK Investigational Site, St Louis

70115

GSK Investigational Site, New Orleans

78229

GSK Investigational Site, San Antonio

97504

GSK Investigational Site, Medford

240564

GSK Investigational Site, Râmnicu Vâlcea

300310

GSK Investigational Site, Timișoara

400371

GSK Investigational Site, Cluj-Napoca

505100

GSK Investigational Site, Codlea

600252

GSK Investigational Site, Bacau

720284

GSK Investigational Site, Suceava

2260000

GSK Investigational Site, Quillota

2520594

GSK Investigational Site, Viña del Mar

3460001

GSK Investigational Site, Talca