236
Participants
Start Date
July 14, 2016
Primary Completion Date
April 27, 2017
Study Completion Date
April 27, 2017
UMEC/VI
ELLIPTA dry powder inhaler (DPI) will contain a total of 30 doses. Each DPI will be comprised of two double-foil, laminate blister strips. Each blister of one strip will consist of 62.5 mcg of UMEC blended with lactose and magnesium stearate while each blister of other strip will consist of 25 mcg of VI blended with lactose and magnesium stearate. Each actuation of the DPI will deliver the contents of one blister from each strip simultaneously
TIO/OLO
TIO/OLO inhalation spray will be supplied as an inhalation spray delivered using a RESPIMAT inhaler. Each actuation from the RESPIMAT inhaler delivers 3.124 mcg tiotropium bromide monohydrate (equivalent to 2.5 mcg tiotropium) and 2.736 mcg olodaterol hydrochloride (equivalent to 2.5 mcg olodaterol)
Albuterol/salbutamol
Albuterol/salbutamol will be supplied as an inhalation spray via metered dose inhaler and will be issued for reversibility testing at Visit 1. Albuterol/salbutamol will be permitted throughout the study for use as-needed
GSK Investigational Site, Girona
GSK Investigational Site, Loja/ Granada
GSK Investigational Site, Richmond
GSK Investigational Site, Ponferrada (León)
GSK Investigational Site, Morgantown
GSK Investigational Site, Spartanburg
GSK Investigational Site, Marbella - Málaga
GSK Investigational Site, Greenville
GSK Investigational Site, Hanover
GSK Investigational Site, Orlando
GSK Investigational Site, Clearwater
GSK Investigational Site, Magdeburg
GSK Investigational Site, Jerichow
GSK Investigational Site, Valladolid
GSK Investigational Site, Frankfurt am Main
GSK Investigational Site, Frankfurt am Main
GSK Investigational Site, St Louis
GSK Investigational Site, Neu-Isenburg
GSK Investigational Site, Medford
GSK Investigational Site, Charleston
GSK Investigational Site, Dresden
GSK Investigational Site, Leipzig
GSK Investigational Site, Alicante
GSK Investigational Site, Mérida (Badajoz)
GSK Investigational Site, Cheadle
GSK Investigational Site, Chesterfield
GSK Investigational Site, Romford
GSK Investigational Site, Manchester
GSK Investigational Site, Salford
GSK Investigational Site, Northwood
GSK Investigational Site, Addlestone
GSK Investigational Site, Bristol
GSK Investigational Site, Chippenham
GSK Investigational Site, Sidcup, Kent
GSK Investigational Site, Swinton
Lead Sponsor
GlaxoSmithKline
INDUSTRY