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

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary purpose of the study is to evaluate the safety and tolerability of fluticasone furoate/GW642444 inhalation powder when administered once-daily for 52 weeks in Japanese patients with COPD.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Fluticasone; Xhance

Criteria

Inclusion Criteria:

• Out patient at least 40 years of age

• Both genders; females childbearing potencial must be willing to use birth control method

• A diagnosis of COPD at Screening

• Subjects with a current or prior history of at least 10 pack-years of cigarett smoking at Screening

• Post-bronchodilator FEV1/FVC ratio of less than 70%

• Post-bronchodilator FEV1 of less than 80%

Exclusion Criteria:

• Current diagnosis of sthma

• Respiratory disorders other than COPD

• Upper or lower respiratory infection, or exacerbation of COPD within 4 weeka prior to Screening

• Concurrent other disease that would confound study participation or affect subject safety

• Allergies to study drugs, study drugs' excipients, medications related to study drugs

• Taking another investigational medication or medication prohibited for use during this study