A Study to Evaluate the Effect of Umeclidinium (UMEC) as Combination Therapy in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

PHASE4CompletedINTERVENTIONAL
Enrollment

236

Participants

Timeline

Start Date

September 30, 2014

Primary Completion Date

March 24, 2015

Study Completion Date

March 24, 2015

Conditions
Pulmonary Disease, Chronic Obstructive
Interventions
DRUG

UMEC DPI

The UMEC DPI will contain one blister strip which will have 30 blisters of UMEC as dry powder blended with lactose and magnesium stearate, with no companion strip. Each actuation of the DPI will deliver the contents of one blister from each strip simultaneously.

DRUG

Placebo DPI

The matching placebo DPI, identical in appearance to the inhaler containing active study medication, will have two blister strips, each containing 30 blisters of lactose and magnesium stearate.

DRUG

ICS/LABA medication

Participants will use ICS/LABA combinations that are approved for the treatment of COPD at approved doses and frequency including SERETIDE 500/50mcg twice daily, FSC 500/50 mcg twice daily generic products such as AIRFLUSAL FORSPIRO inhaler 500/50mcg twice daily or ROLENIUM ELPENHALER inhaler 500/50mcg twice daily and SYMBICORT TURBUHALER inhaler at doses of 200/6mcg twice daily and 400/12mcg twice daily. The ICS/LABA will be sourced from local commercial stock while on the study

DRUG

Albuterol/salbutamol Metered Dose Inhaler (MDI)

Albuterol/salbutamol MDI or nebules will be issued throughout the study as rescue medication, for use as-needed. Albuterol/salbutamol will be sourced from local commercial stock or provided centrally from GlaxoSmithKline.

Trial Locations (28)

10629

GSK Investigational Site, Berlin

13125

GSK Investigational Site, Berlin

14059

GSK Investigational Site, Berlin

14467

GSK Investigational Site, Potsdam

45355

GSK Investigational Site, Essen

47574

GSK Investigational Site, Goch

51069

GSK Investigational Site, Cologne

56403

GSK Investigational Site, Thessaloniki

57010

GSK Investigational Site, Thessaloniki

60596

GSK Investigational Site, Frankfurt am Main

65500

GSK Investigational Site, Kavala

66434

GSK Investigational Site, Kuřim

71110

GSK Investigational Site, Heraklion, Crete

74100

GSK Investigational Site, Rethymnon, Crete

80339

GSK Investigational Site, Munich

89407

GSK Investigational Site, Dillingen an der Donau

772 00

GSK Investigational Site, Olomouc

337 01

GSK Investigational Site, Rokycany

415 10

GSK Investigational Site, Teplice

438 01

GSK Investigational Site, Žatec

115 27

GSK Investigational Site, Athens

564 29

GSK Investigational Site, N. Efkarpia, Thessaloniki

7609 PP

GSK Investigational Site, Almelo

4818 CK

GSK Investigational Site, Breda

5623 EJ

GSK Investigational Site, Eindhoven

3844 DG

GSK Investigational Site, Harderwijk

1624 NP

GSK Investigational Site, Hoorn

7694 AC

GSK Investigational Site, Kloosterhaar

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY