198
Participants
Start Date
January 23, 2015
Primary Completion Date
June 2, 2016
Study Completion Date
June 2, 2016
UMEC/VI DPI
The 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 62.5mcg 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
Placebo DPI
The 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.
Albuterol/salbutamol MDI
Albuterol/salbutamol MDI (metered-dose inhaler) or nebules will be permitted throughout the study as rescue medication, for use as-needed. Albuterol/salbutamol will be sourced from local commercial stock or provided centrally from GlaxoSmithKline. Nebules will not be supplied.
GSK Investigational Site, Charlotte
GSK Investigational Site, Spartanburg
GSK Investigational Site, Gaffney
GSK Investigational Site, Union
GSK Investigational Site, Greenville
GSK Investigational Site, Anderson
GSK Investigational Site, Easley
GSK Investigational Site, Jasper
GSK Investigational Site, Saint Charles
GSK Investigational Site, Medford
Lead Sponsor
GlaxoSmithKline
INDUSTRY