A Long-term Safety Study of Fluticasone Furoate (FF)/GW642444 and FF in Japanese Subjects With Asthma

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 3

Conditions

Asthma

Treatments

Drug: Fluticasone Furoate/GW642444 Inhalation Powder

Drug: Fluticasone Furoate Inhalation Powder

Study type

Interventional

Funder types

Industry

Identifiers

NCT01244984

113989

Details and patient eligibility

About

The primary purpose of the study is to assess the safety and tolerability of 52-week teatment with fluticasone furoate/GW642444 inhalation powder once-daily and FF inhalation powder once-daily in Japanese adult subjects with asthma.

Enrollment

243 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Out patient at least 18 years of age
Both genderds; females of childbearing potential must be willing to use birth control method
A diagnosis of asthma at least 6 months prior to Screening
A best FEV1 of at least 50% of the predicted nomal value at Screening
Subjects have been receiving maintanance therapy for asthma, for at least 4 weeks prior to Screening

Exclusion criteria

History of life-threating asthma
Respiratory infection or oral candidiasis
Asthma exacerbation within 12 weeks
Concurrent respiratory disease or other disease that would confound study participation or affect subject safety
Allergies to study drugs, study drugs7 excipients, medications related to study drugs
Taking another investigational medication or medication prohibited for use during this study