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Study in Patients With COPD

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ClinicalTrials.gov Identifier: NCT00215449
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : November 11, 2010
Sponsor:
Information provided by:
Dey

Brief Summary:
The purpose of this study is to determine the efficacy and safety of the investigational drug in the treatment of COPD in comparison with a placebo.

Condition or disease Intervention/treatment Phase
COPD Drug: Formoterol Fumarate Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 690 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Actual Primary Completion Date : December 2005
Actual Study Completion Date : April 2006

Resource links provided by the National Library of Medicine





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:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Medical diagnosis of COPD
  • Current or prior history of cigarette smoking

Exclusion Criteria:

  • Medical diagnosis of asthma
  • Chest x-ray (CXR) prior to Day 1 diagnostic of significant disease other than COPD
  • Significant condition or disease other than COPD

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): NCT00215449


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Sponsors and Collaborators
Dey

Publications of Results:
Responsible Party: Director, Clinical Affairs, Dey
ClinicalTrials.gov Identifier: NCT00215449     History of Changes
Other Study ID Numbers: DL-059
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: November 11, 2010
Last Verified: January 2009

Keywords provided by Dey:
Chronic Obstructive Pulmonary Disease
COPD
formoterol
formoterol fumarate

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