Status:
COMPLETED
A Trial to Assess the Pharmacodynamic Response in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Lead Sponsor:
Dey
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
40+ years
Phase:
PHASE2
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
468 Patients enrolled
Trial Details
Trial ID
NCT01168310
Start Date
August 1 2010
End Date
October 1 2011
Last Update
May 27 2013
Active Locations (23)
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1
Investigative Site
Phoenix, Arizona, United States
2
Investigative Site
Fullerton, California, United States
3
Investigative Site
San Diego, California, United States
4
Investigative Site
Clearwater, Florida, United States