729
Participants
Start Date
June 25, 2018
Primary Completion Date
March 14, 2019
Study Completion Date
March 14, 2019
budesonide/formoterol
Subjects will be administered two inhalations of budesonide/formoterol via MDI twice daily
albuterol/salbutamol
Subjects will be provided short-acting albuterol/salbutamol as-rescue medication to be used on an as-needed basis throughout the study.
FF/UMEC/VI
Subjects will receive FF/UMEC/VI 100/62.5/25 mcg via ELLIPTA once daily in the morning
Placebo to match budesonide/formoterol
Subjects will be administered two inhalations of matching placebo twice daily via MDI
tiotropium
Subjects will receive tiotropium (18 mcg) once daily in the morning via HandiHaler device
Placebo to match FF/UMEC/VI
Matching placebo to FF/UMEC/VI will be administered via ELLIPTA once daily in the morning.
placebo to match tiotropium
Subjects will receive tiotropium matching placebo via Handihaler once daily in the morning
ELLIPTA
Subjects will receive FF/UMEC/VI 100/62.5/25 mcg and matching placebo via ELLIPTA in the treatment period. Budesonide/formoterol plus tiotropium once daily plus placebo will be administered via ELLIPTA during the run-in period.
MDI
Subjects will receive budesonide/formoterol and placebo to match budesonide/formoterol via MDI in the treatment period.
HandiHaler
Subjects will be administered tiotropium (18 mcg) or placebo to match tiotropium via HandiHaler during the treatment period.
GSK Investigational Site, The Bronx
GSK Investigational Site, Berlin
GSK Investigational Site, Rüdersdorf
GSK Investigational Site, Hamburg
GSK Investigational Site, Großhansdorf
GSK Investigational Site, Raleigh
GSK Investigational Site, Shelby
GSK Investigational Site, Asheville
GSK Investigational Site, Columbia
GSK Investigational Site, Spartanburg
GSK Investigational Site, Mt. Pleasant
GSK Investigational Site, Greenville
GSK Investigational Site, Anderson
GSK Investigational Site, Easley
GSK Investigational Site, Fort Mill
GSK Investigational Site, Lancaster
GSK Investigational Site, Rock Hill
GSK Investigational Site, Peachtree Corners
GSK Investigational Site, Hanover
GSK Investigational Site, Hanover
GSK Investigational Site, Port Orange
GSK Investigational Site, Edgewater
GSK Investigational Site, DeBary
GSK Investigational Site, Miami
GSK Investigational Site, Miami
GSK Investigational Site, Miami
GSK Investigational Site, Miami
GSK Investigational Site, Clearwater
GSK Investigational Site, Clearwater
GSK Investigational Site, Port Charlotte
GSK Investigational Site, Ocala
GSK Investigational Site, Ocala
GSK Investigational Site, Columbus
GSK Investigational Site, Columbus
GSK Investigational Site, Dayton
GSK Investigational Site, Flint
GSK Investigational Site, Woodbury
GSK Investigational Site, Fridley
GSK Investigational Site, Frankfurt am Main
GSK Investigational Site, Tulsa
GSK Investigational Site, Houston
GSK Investigational Site, Tomball
GSK Investigational Site, Cypress
GSK Investigational Site, Baytown
GSK Investigational Site, Albuquerque
GSK Investigational Site, Gold River
GSK Investigational Site, Portland
GSK Investigational Site, Jindřichův Hradec
GSK Investigational Site, Kralupy nad Vltavou
GSK Investigational Site, Lovosice
GSK Investigational Site, Rokycany
GSK Investigational Site, Teplice
GSK Investigational Site, Breda
GSK Investigational Site, Heerlen
GSK Investigational Site, Hengelo
GSK Investigational Site, Hoorn
GSK Investigational Site, Zutphen
Lead Sponsor
GlaxoSmithKline
INDUSTRY