A Study to Evaluate the Efficacy and Safety of Umeclidinium Bromide/Vilanterol Compared With Fluticasone Propionate/Salmeterol Over 12 Weeks in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

PHASE3CompletedINTERVENTIONAL
Enrollment

717

Participants

Timeline

Start Date

April 4, 2013

Primary Completion Date

October 1, 2013

Study Completion Date

October 7, 2013

Conditions
Pulmonary Disease, Chronic Obstructive
Interventions
DRUG

Umeclidinium bromide/Vilanterol

Dry white powder of UMEC 62.5 mcg per blister and VI 25 mcg per blister as NDPI with 30 doses (2 strips with 30 blisters per strip).

DRUG

Placebo ACCUHALER/DISKUS

Dry white powder of matching placebo as multidose dry powder inhaler containing a foil strip with 60 blisters (1 strip with 60 blisters per strip).

DRUG

Fluticasone propionate/Salmeterol

Dry white powder of fluticasone propionate 500 mcg per blister 50 mcg salmeterol per blister as multidose dry powder inhaler containing a foil strip with 60 blisters (1 strip with 60 blisters per strip).

DRUG

Placebo NDPI

Dry white powder of matching placebo as NDPI with 30 doses (2 strips with 30 blisters per strip).

Trial Locations (78)

2040

GSK Investigational Site, Budaörs

2100

GSK Investigational Site, Gödöllő

2400

GSK Investigational Site, Copenhagen

2650

GSK Investigational Site, Hvidovre

2660

GSK Investigational Site, Balassagyarmat

3529

GSK Investigational Site, Miskolc

3800

GSK Investigational Site, Szikszó

4000

GSK Investigational Site, Roskilde

4032

GSK Investigational Site, Debrecen

4043

GSK Investigational Site, Debrecen

4400

GSK Investigational Site, Nyíregyháza

5000

GSK Investigational Site, Odense C

6722

GSK Investigational Site, Szeged

8000

GSK Investigational Site, Székesfehérvár

8552

GSK Investigational Site, Farkasgyepű

9200

GSK Investigational Site, Mosonmagyaróvár

10117

GSK Investigational Site, Berlin

10629

GSK Investigational Site, Berlin

10717

GSK Investigational Site, Berlin

10787

GSK Investigational Site, Berlin

10789

GSK Investigational Site, Berlin

13125

GSK Investigational Site, Berlin

15562

GSK Investigational Site, Rüdersdorf

19055

GSK Investigational Site, Schwerin

24411

GSK Investigational Site, Ponferrada (León)

28041

GSK Investigational Site, Madrid

39112

GSK Investigational Site, Magdeburg

47012

GSK Investigational Site, Valladolid

60389

GSK Investigational Site, Frankfurt am Main

60596

GSK Investigational Site, Frankfurt am Main

63263

GSK Investigational Site, Neu-Isenburg

89407

GSK Investigational Site, Dillingen an der Donau

115446

GSK Investigational Site, Moscow

123182

GSK Investigational Site, Moscow

123367

GSK Investigational Site, Moscow

185019

GSK Investigational Site, Petrozavodsk

194356

GSK Investigational Site, Saint Petersburg

196247

GSK Investigational Site, Saint Pertersburg

248007

GSK Investigational Site, Kaluga

390039

GSK Investigational Site, Ryazan

410028

GSK Investigational Site, Saratov

420015

GSK Investigational Site, Kazan'

450000

GSK Investigational Site, Ufa

460018

GSK Investigational Site, Orenburg

603126

GSK Investigational Site, Nizhny Novgorod

628012

GSK Investigational Site, Khantymansiysk

656038

GSK Investigational Site, Barnaul

675000

GSK Investigational Site, Blagoveshchensk

256 30

GSK Investigational Site, Benešov

471 54

GSK Investigational Site, Cvikov

278 01

GSK Investigational Site, Kralupy nad Vltavou

767 55

GSK Investigational Site, Kroměříž

150 00

GSK Investigational Site, Prague

337 01

GSK Investigational Site, Rokycany

415 10

GSK Investigational Site, Teplice

674 01

GSK Investigational Site, Třebíč

04509

GSK Investigational Site, Delitzsch

01069

GSK Investigational Site, Dresden

H-7621

GSK Investigational Site, Pécs

3318 AT

GSK Investigational Site, Dordrecht

5623 EJ

GSK Investigational Site, Eindhoven

6419 PC

GSK Investigational Site, Heerlen

1624 NP

GSK Investigational Site, Hoorn

7694 AC

GSK Investigational Site, Kloosterhaar

8601 ZR

GSK Investigational Site, Sneek

80-169

GSK Investigational Site, Gdansk

88-100

GSK Investigational Site, Inowrocław

31-024

GSK Investigational Site, Krakow

60-773

GSK Investigational Site, Poznan

96-100

GSK Investigational Site, Skierniewice

76-200

GSK Investigational Site, Słupsk

105 077

GSK Investigational Site, Moscow

121 309

GSK Investigational Site, Moscow

634 050

GSK Investigational Site, Tomsk

08017

GSK Investigational Site, Barcelona

03004

GSK Investigational Site, Alicante

08907

GSK Investigational Site, L'Hospitalet de Llobregat

07010

GSK Investigational Site, Pama de Mallorca

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY