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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00215436
First Posted: September 22, 2005
Last Update Posted: November 10, 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 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: March 2005
Study Completion Date: September 2006
Primary Completion Date: September 2005 (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:   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): NCT00215436


  Show 44 Study Locations
Sponsors and Collaborators
Dey
  More Information

Publications:
Responsible Party: Director Clinical Affairs, Dey L.P.
ClinicalTrials.gov Identifier: NCT00215436     History of Changes
Other Study ID Numbers: 201-065
First Submitted: September 13, 2005
First Posted: September 22, 2005
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