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

PHASE3CompletedINTERVENTIONAL
Enrollment

700

Participants

Timeline

Start Date

June 13, 2013

Primary Completion Date

January 1, 2014

Study Completion Date

January 9, 2014

Conditions
Pulmonary Disease, Chronic Obstructive
Interventions
DRUG

UMEC/VI Inhalation Powder 62.5/25 mcg via NDPI

The drug is administered via NDPI as one inhalation once daily in the morning. NDPI has two strips, each containing 30 blisters of medication. The first strip has UMEC blended with lactose and magnesium stearate in the form of dry white powder with a dosage of 62.5 mcg per blister and the second strip has VI blended with lactose and magnesium stearate in the form of dry white powder with a dosage of 25 mcg per blister.

DRUG

FSC Inhalation Powder 250/50 mcg via ACCUHALER/DISKUS

The drug is administered via ACCUHALER/DISKUS inhaler as one inhalation each morning and evening. The inhaler contains a single strip with 60 blisters of medication. The strip has 250 mcg of fluticasone propionate and 50 mcg of salmeterol per blister in the form of dry white powder.

DRUG

Placebo DISKUS

Placebo is administered via ACCUHALER/DISKUS inhaler as one inhalation each morning and evening. The inhaler contains 1 strip with 60 blisters of placebo in the form of dry white powder.

DRUG

Placebo NDPI

Placebo is administered via NDPI as one inhalation once daily in the morning. The inhaler contains 2 strips with 30 blisters of placebo per strip in the form of dry white powder.

Trial Locations (72)

1459

GSK Investigational Site, Reiger Park

2040

GSK Investigational Site, Kløfta

2317

GSK Investigational Site, Hamar

4001

GSK Investigational Site, Durban

4005

GSK Investigational Site, Stavanger

7030

GSK Investigational Site, Trondheim

7130

GSK Investigational Site, Somerset West

7700

GSK Investigational Site, Mowbray

7764

GSK Investigational Site, Gatesville

8005

GSK Investigational Site, Bodø

9301

GSK Investigational Site, Bloemfontein

14050

GSK Investigational Site, México DF

23606

GSK Investigational Site, Newport News

28207

GSK Investigational Site, Charlotte

29379

GSK Investigational Site, Union

29615

GSK Investigational Site, Greenville

29640

GSK Investigational Site, Easley

29678

GSK Investigational Site, Seneca

32720

GSK Investigational Site, DeLand

44100

GSK Investigational Site, Guadalajara

63141

GSK Investigational Site, St Louis

64000

GSK Investigational Site, Monterrey

64020

GSK Investigational Site, Monterrey

68000

GSK Investigational Site, Oaxaca City

83814

GSK Investigational Site, Coeur d'Alene

85723

GSK Investigational Site, Tucson

92506

GSK Investigational Site, Riverside

92663

GSK Investigational Site, Newport Beach

97504

GSK Investigational Site, Medford

98055

GSK Investigational Site, Renton

105229

GSK Investigational Site, Moscow

150002

GSK Investigational Site, Yaroslavl

150003

GSK Investigational Site, Yaroslavl

150010

GSK Investigational Site, Yaroslavl

153000

GSK Investigational Site, Arkhangelsk

153005

GSK Investigational Site, Ivanovo

194356

GSK Investigational Site, Saint Petersburg

198216

GSK Investigational Site, Saint Petersburg

200515

GSK Investigational Site, Craiova

394066

GSK Investigational Site, Voronezh

400371

GSK Investigational Site, Cluj-Napoca

410053

GSK Investigational Site, Saratov

426063

GSK Investigational Site, Izhevsk

432063

GSK Investigational Site, Ulyanovsk

454091

GSK Investigational Site, Chelyabinsk

600023

GSK Investigational Site, Vladimir

617507

GSK Investigational Site, Comuna Alexandru Cel Bun

620039

GSK Investigational Site, Yekaterinburg

620043

GSK Investigational Site, Focşani

620109

GSK Investigational Site, Yekaterinburg

644112

GSK Investigational Site, Omsk

672000

GSK Investigational Site, Chita

690950

GSK Investigational Site, Vladivostok

810003

GSK Investigational Site, Brăila

900002

GSK Investigational Site, Constanța

3460001

GSK Investigational Site, Talca

4070038

GSK Investigational Site, Concepción

4270918

GSK Investigational Site, Talcahuano

7500551

GSK Investigational Site, Santiago

7500710

GSK Investigational Site, Santiago

8207257

GSK Investigational Site, Puente Alto - Santiago

8880465

GSK Investigational Site, Santiago

29406-7108

GSK Investigational Site, Charleston

Unknown

GSK Investigational Site, Temuco

N-5021

GSK Investigational Site, Bergen

010457

GSK Investigational Site, Bucharest

030317

GSK Investigational Site, Bucharest

656 045

GSK Investigational Site, Barnaul

214 019

GSK Investigational Site, Smolensk

634 050

GSK Investigational Site, Tomsk

0184

GSK Investigational Site, Meyerspark

0041

GSK Investigational Site, Die Wilgers

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT01879410 - A Study to Compare the Efficacy and Safety of Umeclidinium/Vilanterol With Fluticasone Propionate/Salmeterol in Subjects With Chronic Obstructive Pulmonary Disease (COPD) | Biotech Hunter | Biotech Hunter