967
Participants
Start Date
October 15, 2014
Primary Completion Date
May 4, 2015
Study Completion Date
May 4, 2015
UMEC/VI
ELLIPTA DPI will be supplied with 30 doses (2 strips with 30 blisters per strip) where first strip contains Umeclidinium bromide (unit dose strengths 62.5 mcg per blister) blended with lactose monohydrate and magnesium stearate 0.6% weight/weight (w/w) of total drug product and second strip contains Vilanterol (unit dose strengths 25 mcg per blister) blended with lactose monohydrate and magnesium stearate 1.0% w/w of total drug product
UMEC/VI matching placebo
ELLIPTA DPI will be supplied with 30 doses (2 strips with 30 blisters per strip) where first strip contains lactose monohydrate and magnesium stearate 0.6% w/w of total drug product and second strip contains lactose monohydrate and magnesium stearate 1.0% w/w of total drug product
Tiotropium
Tiotropium (as bromide monohydrate) inhalation capsules 18 mcg per dose will be supplied along with HANDIHALER inhalers manufactured by Boehringer Ingelheim
Tiotropium matching placebo
Tiotropium matching placebo capsules manufactured by GSK, will contain lactose and will be supplied along with HANDIHALER inhalers
Indacaterol
Indacaterol inhalation capsules 150 mcg per dose will be supplied by GSK along with BREEZHALER inhalers manufactured by Novartis
Indacaterol matching placebo
Indacaterol matching placebo capsules manufactured by GSK, will contain lactose and will be supplied along with BREEZHALER inhalers manufactured by Novartis
Albuterol/salbutamol Metered Dose Inhaler (MDI)
Albuterol/salbutamol MDI or nebules for as needed use will be issued throughout the study. Albuterol/salbutamol will be sourced from local commercial stock. If not available locally, GSK will source centrally
GSK Investigational Site, Budaörs
GSK Investigational Site, Gödöllő
GSK Investigational Site, Balassagyarmat
GSK Investigational Site, Szikszó
GSK Investigational Site, San Miguel de Tucumán
GSK Investigational Site, San Miguel de Tucumán
GSK Investigational Site, Debrecen
GSK Investigational Site, Nyíregyháza
GSK Investigational Site, Mendoza
GSK Investigational Site, Szeged
GSK Investigational Site, Mar del Plata
GSK Investigational Site, Pécs
GSK Investigational Site, Tallinn
GSK Investigational Site, Tallinn
GSK Investigational Site, Berlin
GSK Investigational Site, Berlin
GSK Investigational Site, Berlin
GSK Investigational Site, Rüdersdorf
GSK Investigational Site, Schwerin
GSK Investigational Site, Hamburg
GSK Investigational Site, Hamburg
GSK Investigational Site, Tradate (VA)
GSK Investigational Site, Hamburg
GSK Investigational Site, Novara
GSK Investigational Site, Piacenza
GSK Investigational Site, Pordenone
GSK Investigational Site, Gières
GSK Investigational Site, Magdeburg
GSK Investigational Site, Nantes
GSK Investigational Site, Mantova
GSK Investigational Site, Reims
GSK Investigational Site, Frankfurt am Main
GSK Investigational Site, Frankfurt am Main
GSK Investigational Site, Tarbes
GSK Investigational Site, Perpignan
GSK Investigational Site, Strasbourg
GSK Investigational Site, Haapsalu
GSK Investigational Site, Moscow
GSK Investigational Site, Arkhangelsk
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, Timișoara
GSK Investigational Site, Stavropol
GSK Investigational Site, Cluj-Napoca
GSK Investigational Site, Kazan'
GSK Investigational Site, Ulyanovsk
GSK Investigational Site, Orenburg
GSK Investigational Site, Perm
GSK Investigational Site, Yekaterinburg
GSK Investigational Site, Yekaterinburg
GSK Investigational Site, Tomsk
GSK Investigational Site, Omsk
GSK Investigational Site, Irkutsk
GSK Investigational Site, Constanța
GSK Investigational Site, Santiago
GSK Investigational Site, Santiago
GSK Investigational Site, Santiago
GSK Investigational Site, Puente Alto - Santiago
GSK Investigational Site, Buenos Aires
GSK Investigational Site, Buenos Aires
GSK Investigational Site, Buenos Aires
GSK Investigational Site, Mendoza
GSK Investigational Site, Lima
GSK Investigational Site, Lima
GSK Investigational Site, Lima
GSK Investigational Site, Lima
GSK Investigational Site, Lima
GSK Investigational Site, Elblag
GSK Investigational Site, Krakow
GSK Investigational Site, Ostrów Wielkopolski
GSK Investigational Site, Piekary Śląskie
GSK Investigational Site, Sopot
GSK Investigational Site, Słupsk
GSK Investigational Site, Bucharest
GSK Investigational Site, Bucharest
GSK Investigational Site, Moscow
GSK Investigational Site, Bojnice
GSK Investigational Site, Humenné
GSK Investigational Site, Poprad
GSK Investigational Site, Spišská Nová Ves
GSK Investigational Site, Vráble
Lead Sponsor
GlaxoSmithKline
INDUSTRY