NCT01817764 - A Study to Compare the Efficacy and Safety of Umeclidinium/Vilanterol and Fluticasone Propionate/Salmeterol in Subjects With Chronic Obstructive Pulmonary Disease (COPD) | Biotech Hunter

Enrollment

707

Participants

Timeline

Start Date

March 1, 2013

Primary Completion Date

October 1, 2013

Study Completion Date

October 25, 2013

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

DRUG

Umeclidinium/vilanterol

Dry white powder delivered via NDPI (2 strips with 30 blisters each, first containing UMEC 62.5 mcg per blister and second containing VI 25 mcg per blister), administered as one inhalation of UMEC/VI 62.5/25 mcg once-daily in the morning

DRUG

Fluticasone propionate/salmeterol

Dry white powder delivered via ACCUHALER/DISKUS (1 strip with 60 blisters, containing 250 mcg fluticasone propionate and 50 mcg salmeterol per blister), administered as one inhalation of FSC 250/50 mcg each morning and evening

DRUG

Placebo

Placebo will be administered via ACCUHALER/DISKUS or NDPI. Dry white powder administered as one inhalation each morning and evening via ACCUHALER/DISKUS (1 strip with 60 blisters containing placebo) OR once-daily in the morning via NDPI (2 strips with 30 blisters each, containing placebo)

Trial Locations (59)

4000

GSK Investigational Site, San Miguel de Tucumán

5500

GSK Investigational Site, Mendoza

7600

GSK Investigational Site, Mar del Plata

21018

GSK Investigational Site, Vinnytsia

29303

GSK Investigational Site, Spartanburg

29340

GSK Investigational Site, Gaffney

29615

GSK Investigational Site, Greenville

29732

GSK Investigational Site, Rock Hill

35501

GSK Investigational Site, Jasper

36024

GSK Investigational Site, Poltava

43215

GSK Investigational Site, Columbus

49051

GSK Investigational Site, Dnipropetrovsk

56429

GSK Investigational Site, Thessaloniki

57010

GSK Investigational Site, Thessaloniki

61124

GSK Investigational Site, Kharkiv

71110

GSK Investigational Site, Heraklion, Crete

74100

GSK Investigational Site, Rethymnon, Crete

83003

GSK Investigational Site, Donetsk

83114

GSK Investigational Site, Donetsk

85006

GSK Investigational Site, Phoenix

92103

GSK Investigational Site, San Diego

98603

GSK Investigational Site, Yalta

100184

GSK Investigational Site, Ploieşti

100379

GSK Investigational Site, Ploieşti

240564

GSK Investigational Site, Râmnicu Vâlcea

300310

GSK Investigational Site, Timișoara

400371

GSK Investigational Site, Cluj-Napoca

600252

GSK Investigational Site, Bacau

700115

GSK Investigational Site, Iași

720284

GSK Investigational Site, Suceava

2260000

GSK Investigational Site, Quillota

2341131

GSK Investigational Site, Valparaíso

2570017

GSK Investigational Site, Viña del Mar

7500800

GSK Investigational Site, Santiago

8380453

GSK Investigational Site, Santiago

8910131

GSK Investigational Site, Santiago

33765-2616

GSK Investigational Site, Clearwater

C1425AGC

GSK Investigational Site, Ciudad Autonoma de Buenos Aires

C1424BSF

GSK Investigational Site, Buenos Aires

C1425BEN

GSK Investigational Site, Buenos Aires

C1425FVH

GSK Investigational Site, Buenos Aires

C1426ABP

GSK Investigational Site, Buenos Aires

M5500CCG

GSK Investigational Site, Mendoza

Unknown

GSK Investigational Site, Santiago

106 76

GSK Investigational Site, Athens

115 27

GSK Investigational Site, Athens

151 26

GSK Investigational Site, Athens

124 62

GSK Investigational Site, Haidari / Athens

Lima 27

GSK Investigational Site, Lima

020125

GSK Investigational Site, Bucharest