Status:
COMPLETED
A Long-term Safety Study of Fluticasone Furoate (FF)/GW642444 and FF in Japanese Subjects With Asthma
Lead Sponsor:
GlaxoSmithKline
Conditions:
Asthma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 Japa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
243 Patients enrolled
Trial Details
Trial ID
NCT01244984
Start Date
July 1 2010
End Date
January 1 2012
Last Update
January 11 2017
Active Locations (30)
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1
GSK Investigational Site
Chiba, Japan, 277-0863
2
GSK Investigational Site
Fukuoka, Japan, 802-0083
3
GSK Investigational Site
Fukuoka, Japan, 816-0813
4
GSK Investigational Site
Gifu, Japan, 501-6062