A Study to Assess the Efficacy of Fluticasone Furoate/Vilanterol (FF/VI) Inhalation Powder 100/25 mcg Once Daily Compared With Fluticasone Propionate/Salmeterol Inhalation Powder 250/50 mcg Twice Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

PHASE3CompletedINTERVENTIONAL
Enrollment

828

Participants

Timeline

Start Date

October 15, 2012

Primary Completion Date

June 17, 2013

Study Completion Date

June 17, 2013

Conditions
Pulmonary Disease, Chronic Obstructive
Interventions
DRUG

FF/VI 100/25 Inhalation Powder NDPI

Subjects randomized to the FF/VI Inhalation Powder Novel Dry Powder Inhaler (NDPI) arm will receive a single inhalation of 100 mcg FF and 25 mcg VI via NDPI every morning for 12 weeks.

DRUG

Fluticasone Propionate/Salmeterol 250/50 Inhalation Powder ACCUHALER/DISKUS

Subjects randomized to the Fluticasone Propionate/Salmeterol Inhalation Powder ACCUHALER/DISKUS arm will receive a single inhalation of 250 mcg Fluticasone Propionate and 50 mcg Salmeterol via ACCUHALER/DISKUS once in the morning and once in the evening for 12 weeks.

DRUG

Placebo Inhalation Powder NDPI

Subjects randomized to the Fluticasone Propionate/Salmeterol Inhalation Powder ACCUHALER/DISKUS arm will receive a single inhalation of placebo inhalation powder via NDPI every morning for 12 weeks.

DRUG

Placebo Inhalation Powder ACCUHALER/DISKUS

Subjects randomized to the FF/VI Inhalation Powder NDPI arm will receive a single inhalation of placebo inhalation powder via ACCUHALER/DISKUS once in the morning and once in the evening for 12 weeks.

DRUG

Salbutamol as needed

Salbutamol inhalation powder

Trial Locations (63)

10717

GSK Investigational Site, Berlin

10787

GSK Investigational Site, Berlin

12157

GSK Investigational Site, Berlin

12203

GSK Investigational Site, Berlin

13125

GSK Investigational Site, Berlin

20253

GSK Investigational Site, Hamburg

28207

GSK Investigational Site, Charlotte

29118

GSK Investigational Site, Orangeburg

29303

GSK Investigational Site, Spartanburg

29340

GSK Investigational Site, Gaffney

29379

GSK Investigational Site, Union

29615

GSK Investigational Site, Greenville

29640

GSK Investigational Site, Easley

29678

GSK Investigational Site, Seneca

29732

GSK Investigational Site, Rock Hill

30159

GSK Investigational Site, Hanover

30173

GSK Investigational Site, Hanover

32720

GSK Investigational Site, DeLand

33765

GSK Investigational Site, Clearwater

43215

GSK Investigational Site, Columbus

55125

GSK Investigational Site, Woodbury

60389

GSK Investigational Site, Frankfurt am Main

60596

GSK Investigational Site, Frankfurt am Main

61035

GSK Investigational Site, Kharkiv

61761

GSK Investigational Site, Normal

63263

GSK Investigational Site, Neu-Isenburg

70000

GSK Investigational Site, Bucharest

83814

GSK Investigational Site, Coeur d'Alene

98055

GSK Investigational Site, Renton

100379

GSK Investigational Site, Ploieşti

110084

GSK Investigational Site, Piteşti

150003

GSK Investigational Site, Yaroslavl

194291

GSK Investigational Site, Saint Petersburg

194356

GSK Investigational Site, Saint Petersburg

195271

GSK Investigational Site, Saint Petersburg

240564

GSK Investigational Site, Râmnicu Vâlcea

300310

GSK Investigational Site, Timișoara

305035

GSK Investigational Site, Kursk

400371

GSK Investigational Site, Cluj-Napoca

432063

GSK Investigational Site, Ulyanovsk

454106

GSK Investigational Site, Chelyabinsk

500118

GSK Investigational Site, Brasov

500283

GSK Investigational Site, Brasov

600114

GSK Investigational Site, Bacau

614077

GSK Investigational Site, Perm

630051

GSK Investigational Site, Novosibirsk

630102

GSK Investigational Site, Novosibirsk

650000

GSK Investigational Site, Kemerovo

650002

GSK Investigational Site, Kemerovo

690002

GSK Investigational Site, Vladivostok

700115

GSK Investigational Site, Iași

720284

GSK Investigational Site, Suceava

810003

GSK Investigational Site, Brăila

03050

GSK Investigational Site, Cottbus

04509

GSK Investigational Site, Delitzsch

01069

GSK Investigational Site, Dresden

04109

GSK Investigational Site, Leipzg

04207

GSK Investigational Site, Leipzig

030317

GSK Investigational Site, Bucharest

03680

GSK Investigational Site, Kiev

GSK Investigational Site, Kyiv

03038

GSK Investigational Site, Kyiv

04201

GSK Investigational Site, Kyiv

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT01706328 - A Study to Assess the Efficacy of Fluticasone Furoate/Vilanterol (FF/VI) Inhalation Powder 100/25 mcg Once Daily Compared With Fluticasone Propionate/Salmeterol Inhalation Powder 250/50 mcg Twice Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD) | Biotech Hunter | Biotech Hunter