A Dose-Finding Study Evaluating Safety and Efficacy in Patients With Chronic Obstructive Pulmonary Disease

• Status: Completed
• Trial end date: 2007-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to determine the appropriate dose of fluticasone propionate/formoterol fumarate that is closest to Advair Diskus (fluticasone propionate/salmeterol xinafoate using pulmonary function, safety, and levels of study drug in blood plasma in patients with chronic obstructive pulmonary disease.

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

Details

• Lead Sponsor: Dey
• Treatments: Fluticasone; Fluticasone Propionate, Salmeterol Xinafoate Drug Combination; Formoterol Fumarate; Salmeterol Xinafoate; Xhance

Criteria

Inclusion Criteria:

• Diagnosis of COPD

• Female of child-bearing potential to use adequate birth control

• Smoker or ex-smoker with history of at least 10 years of smoking at least one pack of cigarettes per day

• Meet lung function requirements

Exclusion Criteria:

• Diagnosis of asthma

• Other significant disease than COPD

• Pregnant or lactating female

• Female planning to become pregnant