A Trial to Evaluate the Efficacy and Safety of Formoterol Fumarate in the Treatment of Patients With COPD
A 12-week Double-Blind, Parallel-Group, Placebo- and Active- Controlled Trial to Evaluate the Efficacy and Safety of Formoterol Fumarate Inhalation Solution 20 Mcg in the Treatment of Patients With Chronic Obstructive Pulmonary Disease
1 other identifier
interventional
345
1 country
44
Brief Summary
The purpose of this study is to determine the safety and efficacy of the investigational drug in comparison with a placebo.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2005
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 22, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2006
CompletedNovember 10, 2010
April 1, 2008
6 months
September 13, 2005
November 9, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Measure of lung function
Secondary Outcomes (2)
Change in lung function, as well as vital signs
Physical Exam results, Adverse event reporting, etc
Interventions
Eligibility Criteria
You may qualify if:
- Medical diagnosis of COPD
- Current or prior history of cigarette smoking
You may not qualify if:
- Medical diagnosis of asthma
- Chest X-ray diagnostic of significant disease other than COPD
- Significant condition or disease other than COPD
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Deylead
Study Sites (44)
Research Site
Jasper, Alabama, 35501, United States
Research Site
Phoenix, Arizona, 85006-2666, United States
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Tuscon, Arizona, 85715, United States
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Buena Park, California, 90620, United States
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Huntington Beach, California, 92647, United States
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Long Beach, California, 90806, United States
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Long Beach, California, 90813, United States
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Los Angeles, California, 90048, United States
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San Diego, California, 92120, United States
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Stockton, California, 95207, United States
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Denver, Colorado, 80206, United States
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Wheat Ridge, Colorado, 80033, United States
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Hartford, Connecticut, 06105, United States
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Clearwater, Florida, 33765, United States
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DeLand, Florida, 32720, United States
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Tampa, Florida, 33603, United States
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Woodstock, Georgia, 30189, United States
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Hines, Illinois, 60141, United States
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Normal, Illinois, 61761, United States
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Florence, Kentucky, 41042, United States
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New Orleans, Louisiana, 70115, United States
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Ann Arbor, Michigan, 48106, United States
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Minneapolis, Minnesota, 55402, United States
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Rochester, Minnesota, 55905, United States
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Saint Charles, Missouri, 63301, United States
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St Louis, Missouri, 63122, United States
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Butte, Montana, 59701, United States
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Henderson, Nevada, 89014, United States
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Cherry Hill, New Jersey, 08003, United States
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Summit, New Jersey, 07901, United States
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Albuquerque, New Mexico, 87108, United States
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Camillus, New York, 13031, United States
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Charlotte, North Carolina, 28207, United States
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Cincinnati, Ohio, 45241, United States
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Columbus, Ohio, 43215, United States
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Medford, Oregon, 97504, United States
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Portland, Oregon, 97213, United States
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Cranston, Rhode Island, 02920, United States
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Spartanburg, South Carolina, 29307, United States
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Dallas, Texas, 75231, United States
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San Antonio, Texas, 78229, United States
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Richmond, Virginia, 23225, United States
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Madison, Wisconsin, 53792, United States
Research Site
Milwaukee, Wisconsin, 53209, United States
Related Publications (2)
Nelson HS, Gross NJ, Levine B, Kerwin EM, Rinehart M, Denis-Mize K; Formoterol Study Group. Cardiac safety profile of nebulized formoterol in adults with COPD: a 12-week, multicenter, randomized, double- blind, double-dummy, placebo- and active-controlled trial. Clin Ther. 2007 Oct;29(10):2167-78. doi: 10.1016/j.clinthera.2007.10.007.
PMID: 18042473RESULTGross NJ, Nelson HS, Lapidus RJ, Dunn L, Lynn L, Rinehart M, Denis-Mize K; Formoterol Study Group. Efficacy and safety of formoterol fumarate delivered by nebulization to COPD patients. Respir Med. 2008 Feb;102(2):189-97. doi: 10.1016/j.rmed.2007.10.007.
PMID: 18363201RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 22, 2005
Study Start
March 1, 2005
Primary Completion
September 1, 2005
Study Completion
September 1, 2006
Last Updated
November 10, 2010
Record last verified: 2008-04