943
Participants
Start Date
November 28, 2017
Primary Completion Date
January 10, 2019
Study Completion Date
January 10, 2019
Placebo ELLIPTA
Placebo will be administered via oral inhalation route once daily in the morning.
Nemiralisib ELLIPTA 50 µg
Nemiralisib is a potent and highly selective inhaled PI3Kd inhibitor being developed as an anti-inflammatory for the treatment of inflammatory airways disease. Nemiralisib 50 µg will be administered as a dry powder inhaler via oral inhalation route. In addition, subjects will receive SOC therapy for the index acute moderate or severe exacerbation of COPD.
Nemiralisib ELLIPTA 100 µg
Nemiralisib is a potent and highly selective inhaled PI3Kd inhibitor being developed as an anti-inflammatory for the treatment of inflammatory airways disease. Nemiralisib 100 µg will be administered as a dry powder inhaler via oral inhalation route. In addition, subjects will receive SOC therapy for the index acute moderate or severe exacerbation of COPD.
Nemiralisib ELLIPTA 250 µg
Nemiralisib is a potent and highly selective inhaled PI3Kd inhibitor being developed as an anti-inflammatory for the treatment of inflammatory airways disease. Nemiralisib 250 µg will be administered as a dry powder inhaler via oral inhalation route. In addition, subjects will receive SOC therapy for the index acute moderate or severe exacerbation of COPD.
Nemiralisib ELLIPTA 500 µg
Nemiralisib is a potent and highly selective inhaled PI3Kd inhibitor being developed as an anti-inflammatory for the treatment of inflammatory airways disease. Nemiralisib 500 µg will be administered as a dry powder inhaler via oral inhalation route. In addition, subjects will receive SOC therapy for the index acute moderate or severe exacerbation of COPD.
Nemiralisib ELLIPTA 750 µg
Nemiralisib is a potent and highly selective inhaled PI3Kd inhibitor being developed as an anti-inflammatory for the treatment of inflammatory airways disease. Nemiralisib 750 µg will be administered as a dry powder inhaler via oral inhalation route. In addition, subjects will receive SOC therapy for the index acute moderate or severe exacerbation of COPD.
Albuterol (Salbutamol) MDI or nebules
Albuterol (Salbutamol) MDI or nebules will be provided to all subjects as a rescue medication.
Standard of care therapy
SoC therapy for the index exacerbation is defined as treatment with oral/systemic corticosteroid (prednisone 40 mg/day or equivalent) for 5 days and antibiotic for 7 days. Subjects will receive SoC as prescribed by the Investigator or medically qualified designee. The dose and/or duration of prednisone and/or the antibiotic can be modified according to the Investigator's/medically qualified designee's judgment or according to local country/institution practice.
GSK Investigational Site, Florida
GSK Investigational Site, Rosario
GSK Investigational Site, Westmead
GSK Investigational Site, Gosford
GSK Investigational Site, Santo Tomé
GSK Investigational Site, Clayton
GSK Investigational Site, San Miguel de Tucumán
GSK Investigational Site, Woolloongabba
GSK Investigational Site, Woodville South
GSK Investigational Site, Mendoza
GSK Investigational Site, San Rafael
GSK Investigational Site, Murdoch
GSK Investigational Site, Mar del Plata
GSK Investigational Site, Cáceres
GSK Investigational Site, Berlin
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GSK Investigational Site, Pozuelo de Alarcón/Madrid
GSK Investigational Site, Spartanburg
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GSK Investigational Site, Frankfurt am Main
GSK Investigational Site, Frankfurt am Main
GSK Investigational Site, Chesterfield
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GSK Investigational Site, Aschaffenburg
GSK Investigational Site, Monterrey
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GSK Investigational Site, Omaha
GSK Investigational Site, Lyon
GSK Investigational Site, Colorado Springs
GSK Investigational Site, Rosenheim
GSK Investigational Site, Catania
GSK Investigational Site, Bamberg
GSK Investigational Site, Messina
GSK Investigational Site, Ivanovo
GSK Investigational Site, Veliky Novgorod
GSK Investigational Site, Râmnicu Vâlcea
GSK Investigational Site, Timișoara
GSK Investigational Site, Belgorod
GSK Investigational Site, Ryazan
GSK Investigational Site, Voronezh
GSK Investigational Site, Cluj-Napoca
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GSK Investigational Site, Ulyanovsk
GSK Investigational Site, Chelyabinsk
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GSK Investigational Site, Nizhny Novgorod
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GSK Investigational Site, Comuna Alexandru Cel Bun
GSK Investigational Site, Novosibirsk
GSK Investigational Site, Tomsk
GSK Investigational Site, Kemerovo
GSK Investigational Site, Blagoveshchensk
GSK Investigational Site, Iași
GSK Investigational Site, Suceava
GSK Investigational Site, Charleston
GSK Investigational Site, Ciudad Autonoma de Buenos Aires
GSK Investigational Site, Buenos Aires
GSK Investigational Site, Buenos Aires
GSK Investigational Site, Buenos Aires
GSK Investigational Site, Buenos Aires
GSK Investigational Site, Mendoza
GSK Investigational Site, Edmonton
GSK Investigational Site, Sherwood Park
GSK Investigational Site, Winnipeg
GSK Investigational Site, Windsor
GSK Investigational Site, Montreal
GSK Investigational Site, Québec
GSK Investigational Site, Saint-Charles-Borromée
GSK Investigational Site, Leipzig
GSK Investigational Site, Rome
GSK Investigational Site, Rome
GSK Investigational Site, Alkmaar
GSK Investigational Site, Breda
GSK Investigational Site, Eindhoven
GSK Investigational Site, Groningen
GSK Investigational Site, Harderwijk
GSK Investigational Site, Hoorn
GSK Investigational Site, Rotterdam
GSK Investigational Site, Utrecht
GSK Investigational Site, Zwolle
GSK Investigational Site, Bialystok
GSK Investigational Site, Elblag
GSK Investigational Site, Krakow
GSK Investigational Site, Lubin
GSK Investigational Site, Oława
GSK Investigational Site, Ruda Śląska
GSK Investigational Site, Sosnowiec
GSK Investigational Site, Słupsk
GSK Investigational Site, Tarnów
GSK Investigational Site, Bucharest
GSK Investigational Site, Bucharest
GSK Investigational Site, Barnaul
GSK Investigational Site, Seongnam-si, Gyeonggi-do
GSK Investigational Site, Seoul
GSK Investigational Site, Seoul
GSK Investigational Site, Seoul
GSK Investigational Site, Seoul
GSK Investigational Site, Seoul
GSK Investigational Site, Seoul
GSK Investigational Site, Barcelona
GSK Investigational Site, Elda (Alicante)
GSK Investigational Site, Mérida (Badajoz)
GSK Investigational Site, Orihuela (Alicante)
GSK Investigational Site, Palma de Mallorca
GSK Investigational Site, Pama de Mallorca
GSK Investigational Site, Gothenburg
GSK Investigational Site, Lund
GSK Investigational Site, Chesterfield
GSK Investigational Site, Wishaw
GSK Investigational Site, Blackburn
GSK Investigational Site, Bradford
GSK Investigational Site, Edgbaston
GSK Investigational Site, Edinburgh
GSK Investigational Site, Liverpool
GSK Investigational Site, Sheffield
GSK Investigational Site, Stockton-on-Tees
Lead Sponsor
GlaxoSmithKline
INDUSTRY