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A Trial to Evaluate the Efficacy and Safety of Formoterol Fumarate 20 Mcg/0.5 mL in the Treatment of Patients With COPD

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00280371
First Posted: January 23, 2006
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 the safety and efficacy of the investigational drug in comparison with a placebo.

Condition Intervention Phase
COPD Drug: Formoterol Fumarate Phase 3

Study Type: Interventional
Study Design: 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/0.5 mL Delivered by OMRON MicroAir NE-U22V Nebulizer in the Treatment of Patients With Chronic Obstructive Pulmonary Disease

Resource links provided by NLM:


Further study details as provided by Dey:

Primary Outcome Measures:
  • Measure of lung function

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

Estimated Enrollment: 345
Study Start Date: January 2006
Study Completion Date: May 2007
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
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
  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): NCT00280371


  Show 52 Study Locations
Sponsors and Collaborators
Dey
  More Information

Responsible Party: Director, Clinical Affairs, Dey
ClinicalTrials.gov Identifier: NCT00280371     History of Changes
Other Study ID Numbers: 201-069
First Submitted: January 19, 2006
First Posted: January 23, 2006
Last Update Posted: November 11, 2010
Last Verified: February 2008

Keywords provided by Dey:
COPD
Chronic Obstructive Pulmonary Disease
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