A Study Evaluating Systemic Exposure and Pharmacodynamics in Patients With Chronic Obstructive Pulmonary Disease

A Randomized, Multiple-Dose,Double-Blind,Crossover Trial to Assess the Systemic Exposure of Fluticasone Propionate (FP)/Formoterol Fumarate (FF) Fixed-Dose Combination in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

The purpose of this study is to evaluate the systemic exposure and pharmacodynamics of two doses of nebulized fluticasone/formoterol combination as compared to the monocomponents.

Inclusion Criteria:

• Able to understand the requirements of the study and provide consent
• Medical diagnosis of COPD
• A current or prior history of at least 10-pack years of cigarette smoking
• Female of child-bearing potential to use adequate birth control

Exclusion Criteria:

• Diagnosis of asthma
• Other significant disease than COPD
• Has donated a unit of blood within 30 days of study, or intends to donate
• QTc greater than 0.460 seconds
• Subjects who had radiation or chemotherapy in the previous 12 months
• Subjects who had lung resection
• History of illegal drug abuse or alcohol abuse within the past 5 years