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