A Trial to Evaluate the Efficacy and Safety of Formoterol Fumarate 20 Mcg/0.5 mL 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/0.5 mL Delivered by OMRON MicroAir NE-U22V Nebulizer in the Treatment of Patients With Chronic Obstructive Pulmonary Disease
1 other identifier
interventional
345
1 country
52
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 Jan 2006
Shorter than P25 for phase_3
52 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
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
January 19, 2006
CompletedFirst Posted
Study publicly available on registry
January 23, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2007
CompletedNovember 11, 2010
February 1, 2008
6 months
January 19, 2006
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 (52)
Research Site
Jasper, Alabama, 35501, United States
Research Site
Phoenix, Arizona, 85006-2666, United States
Research Site
Buena Park, California, 90620, United States
Research Site
Costa Mesa, California, 92626, United States
Research Site
Huntington Beach, California, 92647, United States
Research Site
Long Beach, California, 90813, United States
Research Site
San Diego, California, 92120, United States
Research Site
Stockton, California, 95207, United States
Research Site
Walnut Creek, California, 94598, United States
Research Site
Denver, Colorado, 80206, United States
Research Site
Wheat Ridge, Colorado, 80033, United States
Research Site
Clearwater, Florida, 33765, United States
Research Site
DeLand, Florida, 32720, United States
Research Site
Miami Beach, Florida, 33140, United States
Research Site
Tampa, Florida, 33603, United States
Research Site
Atlanta, Georgia, 30309, United States
Research Site
Coeur d'Alene, Idaho, 83814, United States
Research Site
Hines, Illinois, 60141, United States
Research Site
Normal, Illinois, 61761, United States
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Overland Park, Kansas, 66210, United States
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Shawnee Mission, Kansas, 66216, United States
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Topeka, Kansas, 66606, United States
Research Site
North Dartmouth, Massachusetts, 02747, United States
Research Site
Minneapolis, Minnesota, 55402, United States
Research Site
Rochester, Minnesota, 55905, United States
Research Site
St Louis, Missouri, 63122, United States
Research Site
St Louis, Missouri, 63141, United States
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Henderson, Nevada, 89014, United States
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Summit, New Jersey, 07901, United States
Research Site
Camillus, New York, 13030, United States
Research Site
Asheville, North Carolina, 28801, United States
Research Site
Charlotte, North Carolina, 28207, United States
Research Site
Elizabeth City, North Carolina, 27909, United States
Research Site
Raleigh, North Carolina, 27607, United States
Research Site
Cincinnati, Ohio, 45231, United States
Research Site
Cincinnati, Ohio, 45242, United States
Research Site
Oklahoma City, Oklahoma, 73104, United States
Research Site
Medford, Oregon, 97504, United States
Research Site
Portland, Oregon, 97213, United States
Research Site
Upland, Pennsylvania, 19013, 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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Austin, Texas, 78750, United States
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Dallas, Texas, 75231, United States
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Houston, Texas, 77030, United States
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Waco, Texas, 76712, United States
Research Site
South Burlington, Vermont, 05403, United States
Research Site
Abingdon, Virginia, 24210, United States
Research Site
Richmond, Virginia, 23225, United States
Research Site
Tacoma, Washington, 98405, United States
Research Site
Madison, Wisconsin, 53792, United States
Research Site
Milwaukee, Wisconsin, 53209, United States
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
January 19, 2006
First Posted
January 23, 2006
Study Start
January 1, 2006
Primary Completion
July 1, 2006
Study Completion
May 1, 2007
Last Updated
November 11, 2010
Record last verified: 2008-02