Long-term Safety Study for GSK573719/GW642444 in Japanese
Status:
Completed
Trial end date:
2012-12-01
Target enrollment:
Participant gender:
Summary
The objective of this study is to evaluate the safety and tolerability of GSK573719/GW642444
Inhalation Powder 125/25 mcg once-daily. The product will be delivered via the Novel Dry
Powder Inhaler (nDPI) over 52 weeks to Japanese subjects with Chronic Obstructive Pulmonary
Disease (COPD). This is a multi-centre, open-label study evaluating the safety of
GSK573719/GW642444 Inhalation Powder 125/25 mcg. Treatment will be given once-daily in the
morning. The target enrolment is approximately 120 subjects at approximately 20 study centres
in Japan. The total duration of subject participation will be 54-55 weeks, consisting of a
7-14 day run-in period, 52-week treatment period and 1-week follow-up period. Subjects
meeting all of the inclusion criteria and none of the exclusion criteria at screening visit
(Visit 1) will enter 7-14 day run-in period. The run-in period is provided for completion of
baseline safety evaluations and to obtain baseline measures of COPD status. At Visit 2,
eligible subjects will start to take GSK573719/GW642444 125/25 mcg, and enter the treatment
period. This treatment will be delivered via the Novel Dry Powder Inhaler (nDPI) once daily
in the morning for 52 weeks. One nDPI will contain 30 doses of study medication. Subjects
will be instructed to administer medication once daily in the morning for the duration of the
52-week treatment period. Each subject should be advised to adhere to this dosing regimen
throughout the study. There will be a total of 8 study visits including at screening (Visit
1), initiation of treatment (Visit 2), and at 4weeks, 8 weeks, 12 weeks, 24 weeks, 36 weeks,
52 weeks (Visit 3 through Visit 8, respectively). Follow-up (Visit 9) will be conducted by
the phone contact approximately 1 week following the completion/withdrawal of treatment
period. A subject will be considered to have completed the study upon completion of the last
on-treatment visit (Visit 8). At the end of the treatment period, subjects will be prescribed
appropriate COPD medication at the investigator's discretion.