111
Participants
Start Date
June 22, 2017
Primary Completion Date
June 25, 2019
Study Completion Date
June 25, 2019
FF/UMEC/VI 100/62.5/25 mcg
Subjects will self-administer the study treatment via the ELLIPTA device. The ELLIPTA 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. ELLIPTA is a registered trademark of GSK groups of companies.
FF/UMEC/VI 200/62.5/25 mcg
Subjects will self-administer the study treatment via the ELLIPTA device. The ELLIPTA 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. ELLIPTA is a registered trademark of GSK groups of companies.
Salbutamol
Salbutamol is a rescue medication administered via metered-dose inhaler (MDI) which will be used when needed during the study.
ACQ-7
ACQ-7 will be used for the assessment of control status of asthma.
GSK Investigational Site, Gifu
GSK Investigational Site, Gunma
GSK Investigational Site, Gunma
GSK Investigational Site, Hiroshima
GSK Investigational Site, Kagawa
GSK Investigational Site, Kanagawa
GSK Investigational Site, Kyoto
GSK Investigational Site, Okinawa
GSK Investigational Site, Tokyo
GSK Investigational Site, Tokyo
GSK Investigational Site, Tokyo
GSK Investigational Site, Tokyo
GSK Investigational Site, Toyama
Lead Sponsor
Collaborators (3)
York Bioanalytical Solution
INDUSTRY
BI Medical.Inc.
INDUSTRY
SRL Medisearch Inc.
INDUSTRY
Parexel
INDUSTRY
Q2 Solutions
INDUSTRY
GlaxoSmithKline
INDUSTRY