This study evaluates the effect of two medicines on COPD (Chronic Obstructive Pulmonary Disease). The study will last 12 weeks. At the end of 12 weeks of treatment, subjects will stop the study medicines for 2 weeks. The study will involve 6 visits to the clinic. Subjects who elect to undergo bronchoalveolar lavage (BAL) procedures will have 8 study visits. Subjects will give sputum, blood, and in some cases BAL samples. Subjects will have breathing tests and will complete diary cards during the study. All study medicines and examinations will be given at no cost to the study subjects. Both medicines used in this study have been approved by the US FDA.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
180
GSK Investigational Site
Birmingham, Alabama, United States
GSK Investigational Site
Los Angeles, California, United States
GSK Investigational Site
San Diego, California, United States
GSK Investigational Site
Fort Collins, Colorado, United States
GSK Investigational Site
Gainesville, Florida, United States
GSK Investigational Site
Decatur, Georgia, United States
GSK Investigational Site
Iowa City, Iowa, United States
GSK Investigational Site
Durham, North Carolina, United States
GSK Investigational Site
Philadelphia, Pennsylvania, United States
GSK Investigational Site
Philadelphia, Pennsylvania, United States
...and 1 more locations
Percent of sputum neutrophils
Inflammation endpoints: Cell counts in sputum, cell counts and protein markers in BAL, protein markers in blood Clinical endpoints: FEV1 Airway conductance and airway resistance Functional residual capacity Shortness of breath symptoms
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