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Study in Patients With COPD

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00215384
First Posted: September 22, 2005
Last Update Posted: November 11, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Dey
  Purpose
The purpose of this study is to determine which dose of the investigational drug is the most safe and effective compared to the control drug.

Condition Intervention Phase
COPD Drug: Formoterol Fumarate Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Dey:

Primary Outcome Measures:
  • The primary outcome variable is the measure of lung function.

Secondary Outcome Measures:
  • Change in lung function will be examined as a secondary outcome, as well as vital signs, physical examination, adverse even reporting, etc.

Estimated Enrollment: 35
Study Completion Date: October 2005
Primary Completion Date: April 2003 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

-History of COPD and cigarette smoking

Exclusion Criteria:

  • Clinical diagnosis of asthma.
  • Chest X-ray that is diagnostic of a significant pulmonary disease other than COPD
  • Disease of other major organ systems
  Contacts and Locations
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): NCT00215384


Locations
United States, California
Research Site
Los Angeles, California, United States, 90025
Research Site
Upland, California, United States, 91786
United States, Colorado
Research Site
Denver, Colorado, United States, 80206
United States, Illinois
Research Site
Hines, Illinois, United States, 60141
United States, Montana
Research Site
Missoula, Montana, United States, 59804
United States, Oregon
Research Site
Medford, Oregon, United States, 97504
United States, Washington
Research Site
Tacoma, Washington, United States, 98405
Sponsors and Collaborators
Dey
  More Information

Responsible Party: Director, Clinical Affairs, Dey
ClinicalTrials.gov Identifier: NCT00215384     History of Changes
Other Study ID Numbers: DL-052
First Submitted: September 13, 2005
First Posted: September 22, 2005
Last Update Posted: November 11, 2010
Last Verified: February 2008

Keywords provided by Dey:
COPD
formoterol

Additional relevant MeSH terms:
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