Overview

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

Status:
Completed
Trial end date:
2012-01-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
GlaxoSmithKline
Treatments:
Fluticasone
Xhance
Criteria
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