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Study in Patients With COPD

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ClinicalTrials.gov Identifier: NCT00215423
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : November 11, 2010
Information provided by:

Brief Summary:
The purpose of this study is to determine which dose of the investigational drug is the most safe and effective for the treatment of COPD compared to the control drug

Condition or disease Intervention/treatment Phase
COPD Chronic Obstructive Pulmonary Disease Drug: Formoterol Fumarate Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Primary Completion Date : December 2003
Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Measure of lung function

Secondary Outcome Measures :
  1. Change in lung function, as well as vital signs
  2. Physical Exam results, adverse event reporting, etc

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis of COPD
  • History of cigarette smoking

Exclusion Criteria:

  • Clinical diagnosis of asthma
  • Significant pulmonary disease other than COPD
  • Other significant major organ disease(s)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00215423

United States, Arizona
Research Site
Phoenix, Arizona, United States, 85006-2666
United States, Colorado
Research Site
Wheat Ridge, Colorado, United States, 80033
United States, Illinois
Research Site
Hines, Illinois, United States, 60141
United States, Kansas
Research Site
Shawnee Mission, Kansas, United States, 66216
United States, Montana
Research Site
Butte, Montana, United States, 59701
United States, Nebraska
Research Site
Omaha, Nebraska, United States, 68134
United States, Oregon
Research Site
Medford, Oregon, United States, 97504
Sponsors and Collaborators

Responsible Party: Director, Clinical Affairs, Dey
ClinicalTrials.gov Identifier: NCT00215423     History of Changes
Other Study ID Numbers: DL-057
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: November 11, 2010
Last Verified: August 2008

Keywords provided by Dey:
Chronic Obstructive Pulmonary Disease
Formoterol Fumarate

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Formoterol Fumarate
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action