Study in Patients With COPD - Full Text View

Sponsored by:	Dey
Information provided by:	Dey
ClinicalTrials.gov Identifier:	NCT00215449

Purpose

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

Condition	Intervention	Phase
COPD	Drug: Formoterol Fumarate	Phase III

Drug Information available for: Formoterol Arformoterol Arformoterol Tartrate Formoterol fumarate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

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:

690

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 (CXR) prior to Day 1 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: NCT00215449

Show 68 Study Locations

Sponsors and Collaborators

Dey

More Information

Responsible Party:	Dey ( Director, Clinical Affairs )
Study ID Numbers:	DL-059
Study First Received:	September 13, 2005
Last Updated:	February 29, 2008
ClinicalTrials.gov Identifier:	NCT00215449
Health Authority:	United States: Food and Drug Administration

Keywords provided by Dey:

Chronic Obstructive Pulmonary Disease
COPD
formoterol
formoterol fumarate

Study placed in the following topic categories:

Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Formoterol
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Respiratory System Agents
Neurotransmitter Agents
Adrenergic beta-Agonists
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Asthmatic Agents

Adrenergic Agonists
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 14, 2009