A Trial to Assess the Pharmacodynamic Response in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
NCT ID: NCT01168310
Last Updated: 2013-05-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
468 participants
INTERVENTIONAL
2010-08-31
2011-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
Fluticasone Propionate/Formoterol Fumarate
Inhalation Suspension
2
Fluticasone Propionate/Formoterol Fumarate
Inhalation Suspension
3
Fluticasone Propionate/Formoterol Fumarate
Inhalation Suspension
4
Fluticasone Propionate/Formoterol Fumarate
Inhalation Suspension
5
Fluticasone Propionate/Formoterol Fumarate
Inhalation Suspension
6
Formoterol Fumarate
Inhalation Solution
7
Placebo
Inhalation Solution
Interventions
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Fluticasone Propionate/Formoterol Fumarate
Inhalation Suspension
Fluticasone Propionate/Formoterol Fumarate
Inhalation Suspension
Fluticasone Propionate/Formoterol Fumarate
Inhalation Suspension
Fluticasone Propionate/Formoterol Fumarate
Inhalation Suspension
Fluticasone Propionate/Formoterol Fumarate
Inhalation Suspension
Formoterol Fumarate
Inhalation Solution
Placebo
Inhalation Solution
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Days
ALL
No
Sponsors
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Dey
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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191-090
Identifier Type: -
Identifier Source: org_study_id
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