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Study in Patients With COPD

This study has been completed.
Sponsor:
Information provided by:
Dey
ClinicalTrials.gov Identifier:
NCT00215384
First received: September 13, 2005
Last updated: November 10, 2010
Last verified: February 2008
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

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

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Director, Clinical Affairs, Dey
ClinicalTrials.gov Identifier: NCT00215384     History of Changes
Other Study ID Numbers: DL-052
Study First Received: September 13, 2005
Last Updated: November 10, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Dey:
COPD
formoterol

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

ClinicalTrials.gov processed this record on May 16, 2013