Study in Patients With COPD

This study has been completed.
Sponsor:
Information provided by:
Dey
ClinicalTrials.gov Identifier:
NCT00215423
First received: September 13, 2005
Last updated: November 10, 2010
Last verified: August 2008
  Purpose

The purpose of this study is to determine which dose of the investigational drug is the most safe and effective for the treatment of COPD compared to the control drug


Condition Intervention Phase
COPD
Chronic Obstructive Pulmonary Disease
Drug: Formoterol Fumarate
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment

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: 49
Study Completion Date: September 2005
Primary Completion Date: December 2003 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   5 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of COPD
  • History of cigarette smoking

Exclusion Criteria:

  • Clinical diagnosis of asthma
  • Significant pulmonary disease other than COPD
  • Other significant major organ disease(s)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00215423

Locations
United States, Arizona
Research Site
Phoenix, Arizona, United States, 85006-2666
United States, Colorado
Research Site
Wheat Ridge, Colorado, United States, 80033
United States, Illinois
Research Site
Hines, Illinois, United States, 60141
United States, Kansas
Research Site
Shawnee Mission, Kansas, United States, 66216
United States, Montana
Research Site
Butte, Montana, United States, 59701
United States, Nebraska
Research Site
Omaha, Nebraska, United States, 68134
United States, Oregon
Research Site
Medford, Oregon, United States, 97504
Sponsors and Collaborators
Dey
  More Information

Publications:
Responsible Party: Director, Clinical Affairs, Dey
ClinicalTrials.gov Identifier: NCT00215423     History of Changes
Other Study ID Numbers: DL-057
Study First Received: September 13, 2005
Last Updated: November 10, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Dey:
COPD
Chronic Obstructive Pulmonary Disease
Formoterol Fumarate
Formoterol

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Formoterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014