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) -Study 2

PHASE3CompletedINTERVENTIONAL
Enrollment

620

Participants

Timeline

Start Date

October 31, 2013

Primary Completion Date

April 30, 2014

Study Completion Date

April 30, 2014

Conditions
Pulmonary Disease, Chronic Obstructive
Interventions
DRUG

FF

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

DRUG

VI

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 (57)

10119

GSK Investigational Site, Berlin

13156

GSK Investigational Site, Berlin

14059

GSK Investigational Site, Berlin

19055

GSK Investigational Site, Schwerin

20253

GSK Investigational Site, Hamburg

22299

GSK Investigational Site, Hamburg

23606

GSK Investigational Site, Newport News

23858

GSK Investigational Site, Reinfeld

28207

GSK Investigational Site, Charlotte

29303

GSK Investigational Site, Spartanburg

29340

GSK Investigational Site, Gaffney

29615

GSK Investigational Site, Greenville

29732

GSK Investigational Site, Rock Hill

30159

GSK Investigational Site, Hanover

30173

GSK Investigational Site, Hanover

32720

GSK Investigational Site, DeLand

32825

GSK Investigational Site, Orlando

34121

GSK Investigational Site, Kassel

36608

GSK Investigational Site, Mobile

39003

GSK Investigational Site, Tábor

39112

GSK Investigational Site, Magdeburg

45355

GSK Investigational Site, Essen

45359

GSK Investigational Site, Essen

49074

GSK Investigational Site, Osnabrück

51069

GSK Investigational Site, Cologne

52349

GSK Investigational Site, Düren

56068

GSK Investigational Site, Koblenz

58452

GSK Investigational Site, Witten

60596

GSK Investigational Site, Frankfurt am Main

63263

GSK Investigational Site, Neu-Isenburg

63301

GSK Investigational Site, Saint Charles

70378

GSK Investigational Site, Stuttgart

70584

GSK Investigational Site, Sunset

70868

GSK Investigational Site, Ostrava - Poruba

80339

GSK Investigational Site, Munich

83814

GSK Investigational Site, Coeur d'Alene

85006

GSK Investigational Site, Phoenix

89407

GSK Investigational Site, Dillingen an der Donau

92647

GSK Investigational Site, Huntington Beach

278 01

GSK Investigational Site, Kralupy nad Vltavou

772 00

GSK Investigational Site, Olomouc

140 46

GSK Investigational Site, Prague

415 10

GSK Investigational Site, Teplice

01069

GSK Investigational Site, Dresden

04109

GSK Investigational Site, Leipzg

04103

GSK Investigational Site, Leipzig

04207

GSK Investigational Site, Leipzig

04357

GSK Investigational Site, Leipzig

07548

GSK Investigational Site, Gera

04626

GSK Investigational Site, Schmölln

705-717

GSK Investigational Site, Daegu

220-701

GSK Investigational Site, Gangwon-do

130-702

GSK Investigational Site, Seoul

134-701

GSK Investigational Site, Seoul

137-701

GSK Investigational Site, Seoul

152-703

GSK Investigational Site, Seoul

156-707

GSK Investigational Site, Seoul

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT02119286 - 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) -Study 2 | Biotech Hunter | Biotech Hunter