A Non-inferiority Study to Evaluate the Efficacy, Safety, and Tolerability of Fluticasone Propionate/Salmeterol (FSC) 250/50 Microgram (mcg) Through a Capsule-Based Inhaler and a Multi-Dose Inhaler Administered Twice Daily (BID) in Adults With Chronic Obstructive Pulmonary Disease (COPD)

PHASE3CompletedINTERVENTIONAL
Enrollment

665

Participants

Timeline

Start Date

November 14, 2013

Primary Completion Date

April 16, 2015

Study Completion Date

April 16, 2015

Conditions
Pulmonary Disease, Chronic Obstructive
Interventions
DRUG

FSC

Subject will be administered FSC 250 mcg/50 mcg via dry powder inhalation device -or multi-dose dry powder inhalation device BID for each treatment periods

DRUG

Placebo

Subject will be administered placebo via dry powder inhalation device or multi-dose dry powder inhalation device BID for each treatment periods

Trial Locations (52)

1133

GSK Investigational Site, Kyiv

1407

GSK Investigational Site, Buenos Aires

1638

GSK Investigational Site, Florida

1888

GSK Investigational Site, San Juan Bautista

1900

GSK Investigational Site, La Plata

3680

GSK Investigational Site, Kyiv

7600

GSK Investigational Site, Mar del Plata

8000

GSK Investigational Site, Bahía Blanca

18009

GSK Investigational Site, Cherkasy

21029

GSK Investigational Site, Vinnytsia

22010

GSK Investigational Site, Baja California

31203

GSK Investigational Site, Chihuahua City

34270

GSK Investigational Site, Durango

36010

GSK Investigational Site, Poltava

40000

GSK Investigational Site, Sumy

42090

GSK Investigational Site, Hidalgo

44100

GSK Investigational Site, Guadalajara

44130

GSK Investigational Site, Jalisco

44280

GSK Investigational Site, Guadalajara

49005

GSK Investigational Site, Dnipropetrovsk

58005

GSK Investigational Site, Chernivtsi

61039

GSK Investigational Site, Kharkiv

64020

GSK Investigational Site, Monterrey

64460

GSK Investigational Site, Monterrey

65025

GSK Investigational Site, Odesa

69035

GSK Investigational Site, Zaporizhzhia

69050

GSK Investigational Site, Zaporizhzhia

73000

GSK Investigational Site, Kherson

76008

GSK Investigational Site, Ivano-Frankivsk

76018

GSK Investigational Site, Ivano-Frankivsk

150003

GSK Investigational Site, Yaroslavl

192242

GSK Investigational Site, Saint Petersburg

194044

GSK Investigational Site, Saint Petersburg

195271

GSK Investigational Site, Saint Petersburg

214006

GSK Investigational Site, Smolensk

390026

GSK Investigational Site, Ryazan

390039

GSK Investigational Site, Ryazan

440026

GSK Investigational Site, Penza

603011

GSK Investigational Site, Nizhny Novgorod

614068

GSK Investigational Site, Perm

620039

GSK Investigational Site, Yekaterinburg

630099

GSK Investigational Site, Novosibirsk

634003

GSK Investigational Site, Tomsk

634050

GSK Investigational Site, Tomsk

656045

GSK Investigational Site, Barnaul

B1878FNR

GSK Investigational Site, Quilmes

C1180AAX

GSK Investigational Site, Buenos Aires

C1424BSF

GSK Investigational Site, Buenos Aires

C1425BEN

GSK Investigational Site, Buenos Aires

B1824DLR

GSK Investigational Site, Lanús

B1824KAJ

GSK Investigational Site, Lanús

M5500CCG

GSK Investigational Site, Mendoza

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY