A Long-term Safety Study of Fixed Dose Combination Therapy Fluticasone Furoate/Umeclidinium Bromide/Vilanterol Trifenatate in Japanese Subjects With Asthma

PHASE3CompletedINTERVENTIONAL
Enrollment

111

Participants

Timeline

Start Date

June 22, 2017

Primary Completion Date

June 25, 2019

Study Completion Date

June 25, 2019

Conditions
Asthma
Interventions
DRUG

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.

DRUG

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.

DRUG

Salbutamol

Salbutamol is a rescue medication administered via metered-dose inhaler (MDI) which will be used when needed during the study.

OTHER

ACQ-7

ACQ-7 will be used for the assessment of control status of asthma.

Trial Locations (13)

509-6134

GSK Investigational Site, Gifu

372-0831

GSK Investigational Site, Gunma

373-0807

GSK Investigational Site, Gunma

732-0052

GSK Investigational Site, Hiroshima

762-8550

GSK Investigational Site, Kagawa

236-0004

GSK Investigational Site, Kanagawa

607-8062

GSK Investigational Site, Kyoto

901-2121

GSK Investigational Site, Okinawa

103-0027

GSK Investigational Site, Tokyo

134-0083

GSK Investigational Site, Tokyo

157-0066

GSK Investigational Site, Tokyo

169-0073

GSK Investigational Site, Tokyo

937-0042

GSK Investigational Site, Toyama

Sponsors
All Listed Sponsors
collaborator

York Bioanalytical Solution

INDUSTRY

collaborator

BI Medical.Inc.

INDUSTRY

collaborator

SRL Medisearch Inc.

INDUSTRY

collaborator

Parexel

INDUSTRY

collaborator

Q2 Solutions

INDUSTRY

lead

GlaxoSmithKline

INDUSTRY