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

Completed · Phase 2 · Has a placebo group

Conditions studied: Chronic Obstructive Pulmonary Disease

In brief

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.

Key facts

Study ID

NCT01168310

Run by

Dey

People needed

468

Starts

2010-08-01

Expected to finish

2011-10-01

Last updated by the study team

2013-05-27

Who can join

Age: 0 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Investigative Site — Phoenix, Arizona, United States
• Investigative Site — Fullerton, California, United States
• Investigative Site — San Diego, California, United States
• Investigative Site — Clearwater, Florida, United States
• Investigative Site — DeLand, Florida, United States
• Investigative Site — Tamarac, Florida, United States
• Investigative Site — Lawrenceville, Georgia, United States
• Investigative Site — Coeur d'Alene, Idaho, United States
• Investigative Site — Madisonville, Kentucky, United States
• Investigative Site — Sunset, Louisiana, United States
• Investigative Site — St Louis, Missouri, United States
• Investigative Site — Charlotte, North Carolina, United States
• Investigative Site — Raleigh, North Carolina, United States
• Investigative site — Sylvania, Ohio, United States
• Investigative Site — Medford, Oregon, United States
• Investigative Site — Easley, South Carolina, United States
• Investigative Site — Gaffney, South Carolina, United States
• Investigative Site — Greenville, South Carolina, United States
• Investigative Site — Greer, South Carolina, United States
• Investigative Site — Spartanburg, South Carolina, United States
• Invesigative Site — Union, South Carolina, United States
• Investigative Site — San Antonio, Texas, United States
• Investigative Site — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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