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A Trial to Evaluate the Efficacy and Safety of Formoterol Fumarate in the Treatment of Patients With COPD

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ClinicalTrials.gov Identifier: NCT00215436
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : November 10, 2010
Sponsor:
Information provided by:
Dey

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

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

Study Type : Interventional  (Clinical Trial)
Enrollment : 345 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2005
Actual Primary Completion Date : September 2005
Actual Study Completion Date : September 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 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): NCT00215436


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Sponsors and Collaborators
Dey

Publications of Results:
Responsible Party: Director Clinical Affairs, Dey L.P.
ClinicalTrials.gov Identifier: NCT00215436     History of Changes
Other Study ID Numbers: 201-065
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: November 10, 2010
Last Verified: April 2008

Keywords provided by Dey:
Chronic Obstructive Pulmonary Disease
COPD
formoterol

Additional relevant MeSH terms:
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
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