732
Participants
Start Date
June 25, 2018
Primary Completion Date
March 18, 2019
Study Completion Date
March 18, 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, Berlin
GSK Investigational Site, Berlin
GSK Investigational Site, Potsdam
GSK Investigational Site, Jefferson Hills
GSK Investigational Site, Geesthacht
GSK Investigational Site, Richmond
GSK Investigational Site, Lübeck
GSK Investigational Site, Mooresville
GSK Investigational Site, Charlotte
GSK Investigational Site, Spartanburg
GSK Investigational Site, Clinton
GSK Investigational Site, Union
GSK Investigational Site, Mt. Pleasant
GSK Investigational Site, Greenville
GSK Investigational Site, Dacula
GSK Investigational Site, Duluth
GSK Investigational Site, Peine
GSK Investigational Site, Rincon
GSK Investigational Site, Longwood
GSK Investigational Site, Winter Park
GSK Investigational Site, Hialeah
GSK Investigational Site, Miami
GSK Investigational Site, Miami
GSK Investigational Site, Miami
GSK Investigational Site, Miami
GSK Investigational Site, Miami
GSK Investigational Site, Kendall
GSK Investigational Site, Clearwater
GSK Investigational Site, Sebring
GSK Investigational Site, Celebration
GSK Investigational Site, Leesburg
GSK Investigational Site, Mobile
GSK Investigational Site, Tullahoma
GSK Investigational Site, Grove City
GSK Investigational Site, Dortmund
GSK Investigational Site, Cincinnati
GSK Investigational Site, Evansville
GSK Investigational Site, Rochester
GSK Investigational Site, Farmington Hills
GSK Investigational Site, Rheine
GSK Investigational Site, Evanston
GSK Investigational Site, St Louis
GSK Investigational Site, Břeclav
GSK Investigational Site, McKinney
GSK Investigational Site, Boerne
GSK Investigational Site, San Antonio
GSK Investigational Site, San Diego
GSK Investigational Site, Westminster
GSK Investigational Site, Bakersfield
GSK Investigational Site, Sacramento
GSK Investigational Site, Tacoma
GSK Investigational Site, Hlučín
GSK Investigational Site, Karlovy Vary
GSK Investigational Site, Nový Bor
GSK Investigational Site, Varnsdorf
GSK Investigational Site, Cottbus
GSK Investigational Site, Leipzig
Lead Sponsor
GlaxoSmithKline
INDUSTRY