A Trial to Assess the Pharmacodynamic Response in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

• Status: Completed
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized, double-blind, multi-dose, parallel group trial which will assess the pharmacodynamic response of fluticasone propionate and formoterol fumarate in subjects with COPD.

• 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 written informed consent

• A clinical diagnosis of COPD

• A current or prior history of at least 10-pack years of cigarette smoking

• Women of child-bearing potential (WOCBP) must have a negative pregnancy test at the screening visit and agree to avoid becoming pregnant for the duration of study

Exclusion Criteria:

• A clinical diagnosis of Asthma

• Other significant disease than COPD

• Subjects who radiation or chemotherapy within the previous 12 months

• Subjects who had any lung resection

• QTcB greater than 0.460 seconds

• History of illegal drug abuse or alcohol abuse within the past 5 years