236
Participants
Start Date
September 30, 2014
Primary Completion Date
March 24, 2015
Study Completion Date
March 24, 2015
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.
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.
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
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.
GSK Investigational Site, Berlin
GSK Investigational Site, Berlin
GSK Investigational Site, Berlin
GSK Investigational Site, Potsdam
GSK Investigational Site, Essen
GSK Investigational Site, Goch
GSK Investigational Site, Cologne
GSK Investigational Site, Thessaloniki
GSK Investigational Site, Thessaloniki
GSK Investigational Site, Frankfurt am Main
GSK Investigational Site, Kavala
GSK Investigational Site, Kuřim
GSK Investigational Site, Heraklion, Crete
GSK Investigational Site, Rethymnon, Crete
GSK Investigational Site, Munich
GSK Investigational Site, Dillingen an der Donau
GSK Investigational Site, Olomouc
GSK Investigational Site, Rokycany
GSK Investigational Site, Teplice
GSK Investigational Site, Žatec
GSK Investigational Site, Athens
GSK Investigational Site, N. Efkarpia, Thessaloniki
GSK Investigational Site, Almelo
GSK Investigational Site, Breda
GSK Investigational Site, Eindhoven
GSK Investigational Site, Harderwijk
GSK Investigational Site, Hoorn
GSK Investigational Site, Kloosterhaar
Lead Sponsor
GlaxoSmithKline
INDUSTRY