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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:
Information provided by:
Dey
ClinicalTrials.gov Identifier:
NCT00215436
First received: September 13, 2005
Last updated: November 9, 2010
Last verified: April 2008
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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:

U.S. FDA Resources

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

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00215436

  Hide Study Locations
Locations
United States, Alabama
Research Site
Jasper, Alabama, United States, 35501
United States, Arizona
Research Site
Phoenix, Arizona, United States, 85006-2666
Research Site
Tuscon, Arizona, United States, 85715
United States, California
Research Site
Buena Park, California, United States, 90620
Research Site
Huntington Beach, California, United States, 92647
Research Site
Long Beach, California, United States, 90806
Research Site
Long Beach, California, United States, 90813
Research Site
Los Angeles, California, United States, 90048
Research Site
San Diego, California, United States, 92120
Research Site
Stockton, California, United States, 95207
United States, Colorado
Research Site
Denver, Colorado, United States, 80206
Research Site
Wheat Ridge, Colorado, United States, 80033
United States, Connecticut
Research Site
Hartford, Connecticut, United States, 06105
United States, Florida
Research Site
Clearwater, Florida, United States, 33765
Research Site
DeLand, Florida, United States, 32720
Research Site
Tampa, Florida, United States, 33603
United States, Georgia
Research Site
Woodstock, Georgia, United States, 30189
United States, Illinois
Research Site
Hines, Illinois, United States, 60141
Research Site
Normal, Illinois, United States, 61761
United States, Kentucky
Research Site
Florence, Kentucky, United States, 41042
United States, Louisiana
Research Site
New Orleans, Louisiana, United States, 70115
United States, Michigan
Research Site
Ann Arbor, Michigan, United States, 48106
United States, Minnesota
Research Site
Minneapolis, Minnesota, United States, 55402
Research Site
Rochester, Minnesota, United States, 55905
United States, Missouri
Research Site
St Charles, Missouri, United States, 63301
Research Site
St. Louis, Missouri, United States, 63122
United States, Montana
Research Site
Butte, Montana, United States, 59701
United States, Nevada
Research Site
Henderson, Nevada, United States, 89014
United States, New Jersey
Research Site
Cherry Hill, New Jersey, United States, 08003
Research Site
Summit, New Jersey, United States, 07901
United States, New Mexico
Research Site
Albuquerque, New Mexico, United States, 87108
United States, New York
Research Site
Camillus, New York, United States, 13031
United States, North Carolina
Research Site
Charlotte, North Carolina, United States, 28207
United States, Ohio
Research Site
Cincinnati, Ohio, United States, 45241
Research Site
Columbus, Ohio, United States, 43215
United States, Oregon
Research Site
Medford, Oregon, United States, 97504
Research Site
Portland, Oregon, United States, 97213
United States, Rhode Island
Research Site
Cranston, Rhode Island, United States, 02920
United States, South Carolina
Research Site
Spartanburg, South Carolina, United States, 29307
United States, Texas
Research Site
Dallas, Texas, United States, 75231
Research Site
San Antonio, Texas, United States, 78229
United States, Virginia
Research Site
Richmond, Virginia, United States, 23225
United States, Wisconsin
Research Site
Madison, Wisconsin, United States, 53792
Research Site
Milwaukee, Wisconsin, United States, 53209
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
Study First Received: September 13, 2005
Last Updated: November 9, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Dey:
Chronic Obstructive Pulmonary Disease
COPD
formoterol

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
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 June 18, 2013