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

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dey
• Treatments: Fluticasone; Formoterol Fumarate; Xhance

Criteria

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