1,055
Participants
Start Date
June 29, 2016
Primary Completion Date
May 23, 2017
Study Completion Date
May 23, 2017
FF/UMEC/VI
This intervention is provided in two strips. First strip contains FF blended with lactose. It is available as dry white powder, 100 mcg per blister. Second strip contains UMEC and VI blended with lactose and magnesium stearate. It is available as dry white powder, 62.5 mcg per blister UMEC, 25 mcg per blister VI. The intervention is inhaled via the DPI, once daily in the morning. DPI contains 30 doses (2 strips with 30 blisters per strip).
FF/VI
This intervention is provided in two strips. First strip contains FF blended with lactose. It is available as dry white powder, 100 mcg per blister. Second strip contains VI blended with lactose and magnesium stearate. It is available as dry white powder, 25 mcg per blister. The intervention is inhaled via the DPI, once daily in the morning. DPI contains 30 doses (2 strips with 30 blisters per strip).
UMEC
This intervention is available in one strip. The strip contains UMEC blended with lactose and magnesium stearate. The formulation is available as dry white powder, 62.5 mcg per blister. The intervention is inhaled via the DPI, once daily in the morning. DPI contains 30 doses (1 strip with 30 blisters).
Placebo
This intervention is available in one strip. The strip contains lactose. The formulation is available as dry white powder. The intervention is inhaled via the DPI, once daily in the morning. DPI contains 30 doses (1 strip with 30 blisters).
Albuterol/salbutamol
This is a rescue medication administered via metered-dose inhaler (MDI) with a spacer which will be used when needed during the study.
GSK Investigational Site, Randwick
GSK Investigational Site, Maroubra
GSK Investigational Site, Westmead
GSK Investigational Site, Coffs Harbour
GSK Investigational Site, Footscray
GSK Investigational Site, San Miguel de Tucumán
GSK Investigational Site, Golden Beach
GSK Investigational Site, Woodville South
GSK Investigational Site, Mendoza
GSK Investigational Site, Murdoch
GSK Investigational Site, Mar del Plata
GSK Investigational Site, Marseille
GSK Investigational Site, México DF
GSK Investigational Site, Rüdersdorf
GSK Investigational Site, Aguascalientes
GSK Investigational Site, Wardenburg
GSK Investigational Site, Pozuelo de Alarcón/Madrid
GSK Investigational Site, Brest
GSK Investigational Site, Hanover
GSK Investigational Site, Pamplona
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GSK Investigational Site, Toulouse
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GSK Investigational Site, Laredo
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GSK Investigational Site, Nantes
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GSK Investigational Site, Gelsenkirchen
GSK Investigational Site, Warendorf
GSK Investigational Site, Rheine
GSK Investigational Site, Zaragoza
GSK Investigational Site, Pisa
GSK Investigational Site, Frankfurt am Main
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GSK Investigational Site, Monterrey
GSK Investigational Site, Monterrey
GSK Investigational Site, Monterrey
GSK Investigational Site, Perpignan
GSK Investigational Site, Pringy
GSK Investigational Site, Napoli
GSK Investigational Site, Avellino
GSK Investigational Site, Dillingen an der Donau
GSK Investigational Site, Palermo
GSK Investigational Site, Nuremberg
GSK Investigational Site, Moscow
GSK Investigational Site, Arkhangelsk
GSK Investigational Site, Arkhangelsk
GSK Investigational Site, Saint Petersburg
GSK Investigational Site, Saint Petersburg
GSK Investigational Site, Saint Petesburg
GSK Investigational Site, Saint Petersburg
GSK Investigational Site, Râmnicu Vâlcea
GSK Investigational Site, Timișoara
GSK Investigational Site, Cluj-Napoca
GSK Investigational Site, Saratov
GSK Investigational Site, Kazan'
GSK Investigational Site, Kazan'
GSK Investigational Site, Izhevsk
GSK Investigational Site, Ufa
GSK Investigational Site, Târgu Mureş
GSK Investigational Site, Novosibirsk
GSK Investigational Site, Tomsk
GSK Investigational Site, Barnaul
GSK Investigational Site, Barnaul
GSK Investigational Site, Irkutsk
GSK Investigational Site, Suceava
GSK Investigational Site, La Plata
GSK Investigational Site, Buenos Aires
GSK Investigational Site, Buenos Aires
GSK Investigational Site, Mendoza
GSK Investigational Site, Cottbus
GSK Investigational Site, Leipzg
GSK Investigational Site, San Sisto (PG)
GSK Investigational Site, Aichi
GSK Investigational Site, Chiba
GSK Investigational Site, Ehime
GSK Investigational Site, Fukuoka
GSK Investigational Site, Fukuoka
GSK Investigational Site, Fukuoka
GSK Investigational Site, Gifu
GSK Investigational Site, Gunma
GSK Investigational Site, Gunma
GSK Investigational Site, Hokkaido
GSK Investigational Site, Hokkaido
GSK Investigational Site, Hokkaido
GSK Investigational Site, Hyōgo
GSK Investigational Site, Hyōgo
GSK Investigational Site, Ibaraki
GSK Investigational Site, Ibaraki
GSK Investigational Site, Ishikawa
GSK Investigational Site, Ishikawa
GSK Investigational Site, Kagawa
GSK Investigational Site, Kagawa
GSK Investigational Site, Kagawa
GSK Investigational Site, Kanagawa
GSK Investigational Site, Kanagawa
GSK Investigational Site, Kanagawa
GSK Investigational Site, Kyoto
GSK Investigational Site, Kyoto
GSK Investigational Site, Mie
GSK Investigational Site, Niigata
GSK Investigational Site, Okayama
GSK Investigational Site, Osaka
GSK Investigational Site, Shizuoka
GSK Investigational Site, Tokyo
GSK Investigational Site, Tokyo
GSK Investigational Site, Ciudad de México
GSK Investigational Site, Elblag
GSK Investigational Site, Grudziądz
GSK Investigational Site, Kielce
GSK Investigational Site, Krakow
GSK Investigational Site, Ostrow Wilekopolski
GSK Investigational Site, Tarnów
GSK Investigational Site, Bucharest
GSK Investigational Site, Bucharest
GSK Investigational Site, Moscow
GSK Investigational Site, Seoul
GSK Investigational Site, Seoul
GSK Investigational Site, Seoul
GSK Investigational Site, Suwon
GSK Investigational Site, Wonju, Gangwon-do,
GSK Investigational Site, Barcelona
GSK Investigational Site, Mérida (Badajoz)
Lead Sponsor
GlaxoSmithKline
INDUSTRY