- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00215436
A Trial to Evaluate the Efficacy and Safety of Formoterol Fumarate in the Treatment of Patients With COPD
November 9, 2010 updated by: Dey
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
The purpose of this study is to determine the safety and efficacy of the investigational drug in comparison with a placebo.
Study Overview
Study Type
Interventional
Enrollment
345
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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Jasper, Alabama, United States, 35501
- 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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California
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Buena Park, California, United States, 90620
- Research Site
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Huntington Beach, California, United States, 92647
- Research Site
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Long Beach, California, United States, 90806
- Research Site
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Long Beach, California, United States, 90813
- Research Site
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Los Angeles, California, United States, 90048
- Research Site
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San Diego, California, United States, 92120
- Research Site
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Stockton, California, United States, 95207
- Research Site
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Colorado
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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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Florida
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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, 33603
- Research Site
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Georgia
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Woodstock, Georgia, United States, 30189
- 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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Kentucky
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Florence, Kentucky, United States, 41042
- Research Site
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Louisiana
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New Orleans, Louisiana, United States, 70115
- Research Site
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Michigan
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Ann Arbor, Michigan, United States, 48106
- Research Site
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Minnesota
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Minneapolis, Minnesota, United States, 55402
- Research Site
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Rochester, Minnesota, United States, 55905
- Research Site
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Missouri
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St Charles, Missouri, United States, 63301
- Research Site
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St. Louis, Missouri, United States, 63122
- Research Site
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Montana
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Butte, Montana, United States, 59701
- 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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Summit, New Jersey, United States, 07901
- 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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Camillus, New York, United States, 13031
- Research Site
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North Carolina
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Charlotte, North Carolina, United States, 28207
- Research Site
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Ohio
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Cincinnati, Ohio, United States, 45241
- Research Site
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Columbus, Ohio, United States, 43215
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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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Rhode Island
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Cranston, Rhode Island, United States, 02920
- Research Site
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South Carolina
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Spartanburg, South Carolina, United States, 29307
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Texas
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Dallas, Texas, United States, 75231
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San Antonio, Texas, United States, 78229
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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 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.
General Publications
- 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. Erratum In: Clin Ther. 2009 Apr;31(4):920.
- Gross 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.
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
Study Start
March 1, 2005
Primary Completion (Actual)
September 1, 2005
Study Completion (Actual)
September 1, 2006
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 15, 2005
First Posted (Estimate)
September 22, 2005
Study Record Updates
Last Update Posted (Estimate)
November 10, 2010
Last Update Submitted That Met QC Criteria
November 9, 2010
Last Verified
April 1, 2008
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
- 201-065
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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