This is a phase III multicenter, randomized, double-blind, placebo-controlled, parallel-group
study to evaluate the efficacy and safety of GSK573719/GW642444 Inhalation Powder, GSK573719
Inhalation Powder, GW642444 Inhalation Powder and Placebo when administered once-daily via a
Novel Dry Powder Inhaler over a 24-week treatment period in subjects with COPD. Subjects who
meet eligibility criteria at Screening (Visit 1) will complete a 7 to14 day run-in period
followed by a randomization visit (Visit 2) then a 24-week treatment period. There will be a
total of 9 clinic study visits. A follow-up phone contact for adverse event assessment will
be conducted approximately one week after the last study visit (Visit 9 or Early Withdrawal).
The total duration of subject participation in the study will be approximately 27 weeks. A
subset of subjects at selected sites will also perform 24-hour serial spirometry and Holter
monitoring during the study and provide serial blood samples for pharmacokinetic analysis.
Sparse pharmacokinetic sampling for population pharmacokinetic analyses will be obtained from
non-subset subjects. The primary measure of efficacy is clinic visit trough
(pre-bronchodilator and pre-dose) FEV1 on Treatment Day 169. Safety will be assessed by
adverse events, 12-lead ECGs, vital signs, clinical laboratory tests, and 24 hour Holter
monitoring (subset only).