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

Completed · Phase 2

Conditions studied: Chronic Obstructive Pulmonary Disease

In brief

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.

Key facts

Study ID

NCT00774761

Run by

Dey

People needed

97

Starts

2008-11-01

Expected to finish

2009-05-01

Last updated by the study team

2013-05-20

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Investigative Site — San Diego, California, United States
• Investigative Site — Panama City, Florida, United States
• Investigative Site — Madisonville, Kentucky, United States
• Investigative Site — Sunset, Louisiana, United States
• Investigative Site — Charlotte, North Carolina, United States
• Investigative Site — Medford, Oregon, United States
• Investigative Site — Greenville, South Carolina, United States
• Investigative Site — Spartanburg, South Carolina, United States
• Investigative Site — Union, South Carolina, United States
• Investigative Site — San Antonio, Texas, United States
• Investigative Site — Spokane, Washington, United States
• Investigative Site — Tacoma, Washington, United States

Full record on ClinicalTrials.gov

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