2,436
Participants
Start Date
October 13, 2016
Primary Completion Date
February 22, 2019
Study Completion Date
February 22, 2019
FF/UMEC/VI (100/31.25/25) mcg
Dry white powder delivered via the ELLIPTA DPI (one inhalation once-daily \[QD\] in the morning). The ELLIPTA DPI holds 2 individual blister strips with 30 blisters on each strip: the first strip contains FF 100 mcg in each blister and the second strip contains UMEC 31.25 mcg and VI 25 mcg in each blister.
FF/UMEC/VI (100/62.5/25) mcg
Dry white powder delivered via the ELLIPTA DPI (one inhalation, QD in the morning). The ELLIPTA DPI holds 2 individual blister strips with 30 blisters on each strip: the first strip contains FF 100 mcg in each blister and the second strip contains UMEC 62.5 mcg and VI 25 mcg in each blister.
FF/UMEC/VI (200/31.25/25) mcg
Dry white powder delivered via the ELLIPTA DPI (one inhalation, QD in the morning). The ELLIPTA DPI holds 2 individual blister strips with 30 blisters on each strip: the first strip contains FF 200 mcg in each blister and the second strip contains UMEC 31.25 mcg and VI 25 mcg in each blister.
FF/UMEC/VI (200/62.5/25) mcg
Dry white powder delivered via the ELLIPTA DPI (one inhalation, QD in the morning). The ELLIPTA DPI holds 2 individual blister strips with 30 blisters on each strip: the first strip contains FF 200 mcg in each blister and the second strip contains UMEC 62.5 mcg and VI 25 mcg in each blister.
FF/VI (100/25) mcg
Dry white powder delivered via the ELLIPTA DPI (one inhalation, QD in the morning). The ELLIPTA DPI holds 2 individual blister strips with 30 blisters on each strip: the first strip contains FF 100 mcg in each blister and the second strip contains VI 25 mcg in each blister.
FF/VI (200/25) mcg
Dry white powder delivered via the ELLIPTA DPI (one inhalation, QD in the morning). The ELLIPTA DPI holds 2 individual blister strips with 30 blisters on each strip: the first strip contains FF 200 mcg in each blister and the second strip contains VI 25 mcg in each blister.
Fluticasone/salmeterol (FSC)
Dry white powder delivered via the DISKUS DPI (one inhalation twice daily: one in the morning and one in the evening). The DISKUS DPI holds a strip of 60 blisters; each blister contains FP 250 mcg and 50 mcg of salmeterol.
Albuterol/salbutamol
This is a rescue medication administered via metered-dose inhaler (MDI) which will be used when needed during the study.
ELLIPTA DPI
The ELLIPTA device will be used during the stabilization period and the treatment period. The ELLIPTA DPI is a moulded plastic two-sided device that can hold two individual blister strips which contain powder formulation for oral inhalation.
DISKUS DPI
The DISKUS device will be used during the run-in period. The DISKUS DPI is a plastic inhalation delivery system containing a single-foil blister strip of a powder formulation of FSC for oral inhalation.
METERED-DOSE INHALER (MDI)
Albuterol/salbutamol (rescue medication) will be delivered via metered-dose inhaler (MDI) will be used for reversibility testing.
GSK Investigational Site, Middelburg
GSK Investigational Site, Reiger Park
GSK Investigational Site, Florida
GSK Investigational Site, Berazategui
GSK Investigational Site, Rosario
GSK Investigational Site, Randwick
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GSK Investigational Site, Melbourne
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GSK Investigational Site, Aurora
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GSK Investigational Site, Colorado Springs
GSK Investigational Site, Eboli (SA)
GSK Investigational Site, Gilbert
GSK Investigational Site, Scottsdale
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GSK Investigational Site, Palermo
GSK Investigational Site, Rolling Hills Estates
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GSK Investigational Site, San Diego
GSK Investigational Site, Huntington Beach
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GSK Investigational Site, Saint Petersburg
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GSK Investigational Site, Craiova
GSK Investigational Site, Timișoara
GSK Investigational Site, Timișoara
GSK Investigational Site, Belgorod
GSK Investigational Site, Deva
GSK Investigational Site, Krasnodar
GSK Investigational Site, Cluj-Napoca
GSK Investigational Site, Cluj-Napoca
GSK Investigational Site, Cluj-Napoca
GSK Investigational Site, Saratov
GSK Investigational Site, Saratov
GSK Investigational Site, Oradea
GSK Investigational Site, Kazan'
GSK Investigational Site, Izhevsk
GSK Investigational Site, Ulyanovsk
GSK Investigational Site, Samara
GSK Investigational Site, Ufa
GSK Investigational Site, Chelyabinsk
GSK Investigational Site, Orenburg
GSK Investigational Site, Brasov
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GSK Investigational Site, Târgu Mureş
GSK Investigational Site, Bacau
GSK Investigational Site, Perm
GSK Investigational Site, Yekaterinburg
GSK Investigational Site, Khantymansiysk
GSK Investigational Site, Tomsk
GSK Investigational Site, Kemerovo
GSK Investigational Site, Kemerovo
GSK Investigational Site, Krasnoyarsk
GSK Investigational Site, Irkutsk
GSK Investigational Site, Ulan-Ude
GSK Investigational Site, Chita
GSK Investigational Site, Blagoveshchensk
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GSK Investigational Site, Galati
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GSK Investigational Site, San Diego
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GSK Investigational Site, Buenos Aires
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GSK Investigational Site, Mendoza
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GSK Investigational Site, Brampton
GSK Investigational Site, Burlington
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GSK Investigational Site, London
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GSK Investigational Site, Sarnia
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GSK Investigational Site, Waterloo
GSK Investigational Site, Windsor
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GSK Investigational Site, Montreal
GSK Investigational Site, Saint-Charles-Borromée
GSK Investigational Site, Trois-Rivières
GSK Investigational Site, Victoriaville
GSK Investigational Site, Québec
GSK Investigational Site, Leipzg
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GSK Investigational Site, Fukuoka
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GSK Investigational Site, Gifu
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GSK Investigational Site, Hyōgo
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GSK Investigational Site, Hyōgo
GSK Investigational Site, Ibaraki
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GSK Investigational Site, Ibaraki
GSK Investigational Site, Ibaraki
GSK Investigational Site, Kagawa
GSK Investigational Site, Kagawa
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GSK Investigational Site, Kanagawa
GSK Investigational Site, Kanagawa
GSK Investigational Site, Kanagawa
GSK Investigational Site, Kanagawa
GSK Investigational Site, Kanagawa
GSK Investigational Site, Kanagawa
GSK Investigational Site, Kyoto
GSK Investigational Site, Kyoto
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GSK Investigational Site, Mie
GSK Investigational Site, Miyagi
GSK Investigational Site, Miyagi
GSK Investigational Site, Miyagi
GSK Investigational Site, Miyagi
GSK Investigational Site, Miyagi
GSK Investigational Site, Nagano
GSK Investigational Site, Nagasaki
GSK Investigational Site, Nara
GSK Investigational Site, Okayama
GSK Investigational Site, Okinawa
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GSK Investigational Site, Ōita
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GSK Investigational Site, Saitama
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GSK Investigational Site, Shimane
GSK Investigational Site, Shizuoka
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GSK Investigational Site, Tokyo
GSK Investigational Site, Tokyo
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GSK Investigational Site, Tokyo
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GSK Investigational Site, Tokyo
GSK Investigational Site, Tokyo
GSK Investigational Site, Tokyo
GSK Investigational Site, Tokyo
GSK Investigational Site, Tokyo
GSK Investigational Site, Tokyo
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GSK Investigational Site, Toyama
GSK Investigational Site, Yamagata
GSK Investigational Site, Yamagata
GSK Investigational Site, Yamaguchi
GSK Investigational Site, Yamanashi
GSK Investigational Site, Alkmaar
GSK Investigational Site, Almere Stad
GSK Investigational Site, Beek
GSK Investigational Site, Breda
GSK Investigational Site, Eindhoven
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GSK Investigational Site, Rotterdam
GSK Investigational Site, Rotterdam
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GSK Investigational Site, Bialystok
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GSK Investigational Site, Ostrowiec Świętokrzyski
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GSK Investigational Site, Sopot
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GSK Investigational Site, Bucharest
GSK Investigational Site, Bucharest
GSK Investigational Site, Bucharest
GSK Investigational Site, Bucharest
GSK Investigational Site, Bucharest
GSK Investigational Site, Bucharest
GSK Investigational Site, Moscow
GSK Investigational Site, Tomsk
GSK Investigational Site, Pretoria West
GSK Investigational Site, Busan
GSK Investigational Site, Daegu
GSK Investigational Site, Seoul
GSK Investigational Site, Seoul
GSK Investigational Site, Seoul
GSK Investigational Site, Seoul
GSK Investigational Site, Seoul
GSK Investigational Site, Suwon-si, Gyeonggi-do
GSK Investigational Site, Wonju-si, Kanwon-do
GSK Investigational Site, Badalona
GSK Investigational Site, Barcelona
GSK Investigational Site, Barcelona
GSK Investigational Site, Barcelona
GSK Investigational Site, Burgos
GSK Investigational Site, L'Hospitalet de Llobregat
GSK Investigational Site, Aberdeen
GSK Investigational Site, Romford
GSK Investigational Site, Wishaw
GSK Investigational Site, Blackpool
GSK Investigational Site, Northwood
GSK Investigational Site, Corby
GSK Investigational Site, Bexhill-on-Sea
GSK Investigational Site, Bradford
GSK Investigational Site, Edgbaston
GSK Investigational Site, Liverpool
GSK Investigational Site, Sidcup, Kent
GSK Investigational Site, Trowbridge
Lead Sponsor
GlaxoSmithKline
INDUSTRY