Status:
COMPLETED
A Study Evaluating Systemic Exposure and Pharmacodynamics in Patients With Chronic Obstructive Pulmonary Disease
Lead Sponsor:
Dey
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
40+ years
Phase:
PHASE2
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
97 Patients enrolled
Trial Details
Trial ID
NCT00774761
Start Date
November 1 2008
End Date
May 1 2009
Last Update
May 20 2013
Active Locations (12)
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1
Investigative Site
San Diego, California, United States, 92120
2
Investigative Site
Panama City, Florida, United States, 32405
3
Investigative Site
Madisonville, Kentucky, United States, 42431
4
Investigative Site
Sunset, Louisiana, United States, 70584