- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00215449
Study in Patients With COPD
November 10, 2010 updated by: Dey
The purpose of this study is to determine the efficacy and safety of the investigational drug in the treatment of COPD in comparison with a placebo.
Study Overview
Study Type
Interventional
Enrollment
690
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alabama
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Bessemer, Alabama, United States, 35023
- Research Site
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Birmingham, Alabama, United States, 35209
- Research Site
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Arizona
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Phoenix, Arizona, United States, 85006-2666
- Research Site
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Tuscon, Arizona, United States, 85715
- Research Site
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Tuscon, Arizona, United States, 85723
- Research Site
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Tuscon, Arizona, United States, 85745
- Research Site
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California
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Buena Park, California, United States, 90620
- Research Site
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Encinitas, California, United States, 92024
- Research Site
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Huntington Beach, California, United States, 92647
- Research Site
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Los Angeles, California, United States, 90048
- Research Site
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Los Angeles, California, United States, 90095
- Research Site
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Mission Viejo, California, United States, 92691
- Research Site
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San Diego, California, United States, 92120
- Research Site
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Sepulveda, California, United States, 91343
- Research Site
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Stockton, California, United States, 95207
- Research Site
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Walnut Creek, California, United States, 94598
- Research Site
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Colorado
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Colorado Springs, Colorado, United States, 80907
- Research Site
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Denver, Colorado, United States, 80206
- Research Site
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Wheat Ridge, Colorado, United States, 80033
- Research Site
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Connecticut
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Hartford, Connecticut, United States, 06105
- Research Site
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Waterbury, Connecticut, United States, 06708
- Research Site
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Florida
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Bay Pines, Florida, United States, 33744
- Research Site
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Clearwater, Florida, United States, 33765
- Research Site
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DeLand, Florida, United States, 32720
- Research Site
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Tampa, Florida, United States, 33607
- Research Site
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Georgia
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Atlanta, Georgia, United States, 30342
- Research Site
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Blue Ridge, Georgia, United States, 30513
- Research Site
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Illinois
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Hines, Illinois, United States, 60141
- Research Site
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Normal, Illinois, United States, 61761
- Research Site
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Indiana
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Evansville, Indiana, United States, 47714
- Research Site
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Kansas
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Shawnee Mission, Kansas, United States, 66216
- Research Site
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Topeka, Kansas, United States, 66606
- Research Site
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Kentucky
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Louisville, Kentucky, United States, 40215
- Research Site
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Louisiana
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New Orleans, Louisiana, United States, 70115
- Research Site
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Slidell, Louisiana, United States, 70461
- Research Site
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Minnesota
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Edina, Minnesota, United States, 55438
- Research Site
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Minneapolis, Minnesota, United States, 55402
- Research Site
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Minneapolis, Minnesota, United States, 55407
- Research Site
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Minneapolis, Minnesota, United States, 55416
- Research Site
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Rochester, Minnesota, United States, 55905
- Research Site
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Montana
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Butte, Montana, United States, 59701
- Research Site
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Nebraska
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Omaha, Nebraska, United States, 68134
- Research Site
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Papillion, Nebraska, United States, 68046
- Research Site
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Nevada
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Henderson, Nevada, United States, 89014
- Research Site
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New Jersey
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Cherry Hill, New Jersey, United States, 08003
- Research Site
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Springfield, New Jersey, United States, 07081
- Research Site
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New Mexico
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Albuquerque, New Mexico, United States, 87108
- Research Site
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New York
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Larchmont, New York, United States, 10538
- Research Site
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New Hyde Park, New York, United States, 11040
- Research Site
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- Research Site
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Ohio
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Cincinnati, Ohio, United States, 45231
- Research Site
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Cincinnati, Ohio, United States, 45219
- Research Site
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Cincinnati, Ohio, United States, 45245
- Research Site
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Cincinnati, Ohio, United States, 45220
- Research Site
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Cincinnati, Ohio, United States, 45241
- Research Site
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Columbus, Ohio, United States, 43215
- Research Site
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Oregon
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Medford, Oregon, United States, 97504
- Research Site
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Portland, Oregon, United States, 97213
- Research Site
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Pennsylvania
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Easton, Pennsylvania, United States, 18045
- Research Site
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South Carolina
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Spartanburg, South Carolina, United States, 29307
- Research Site
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Texas
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Austin, Texas, United States, 78750
- Research Site
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El Paso, Texas, United States, 79902
- Research Site
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Houston, Texas, United States, 77030
- Research Site
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Houston, Texas, United States, 77024
- Research Site
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San Antonio, Texas, United States, 78229
- Research Site
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Virginia
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Richmond, Virginia, United States, 23225
- Research Site
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Wisconsin
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Madison, Wisconsin, United States, 53792
- Research Site
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Milwaukee, Wisconsin, United States, 53209
- Research Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Medical diagnosis of COPD
- Current or prior history of cigarette smoking
Exclusion Criteria:
- Medical diagnosis of asthma
- Chest x-ray (CXR) prior to Day 1 diagnostic of significant disease other than COPD
- Significant condition or disease other than COPD
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Measure of lung function
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Secondary Outcome Measures
Outcome Measure |
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Change in lung function, as well as vital signs
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Physical Exam results, Adverse Event reporting, etc
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Primary Completion (Actual)
December 1, 2005
Study Completion (Actual)
April 1, 2006
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 14, 2005
First Posted (Estimate)
September 22, 2005
Study Record Updates
Last Update Posted (Estimate)
November 11, 2010
Last Update Submitted That Met QC Criteria
November 10, 2010
Last Verified
January 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Adrenergic Agonists
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Adrenergic beta-2 Receptor Agonists
- Adrenergic beta-Agonists
- Formoterol Fumarate
Other Study ID Numbers
- DL-059
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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