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

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 3

Conditions

Pulmonary Disease, Chronic Obstructive

Treatments

Drug: Fluticasone Furoate/GW642444 Inhalation Powder 200/25mcg

Drug: Fluticasone Furoate/GW642444 Inhalation Powder 100/25mcg

Study type

Interventional

Funder types

Industry

Identifiers

NCT01192191

114156

Details and patient eligibility

About

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.

Enrollment

187 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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