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

History of Changes

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:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Formic acid Formoterol fumarate Formoterol Arformoterol Tartrate

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:	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

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:

Gross NJ, Kerwin E, Levine B, Kim KT, Denis-Mize K, Hamzavi M, Carpenter M, Rinehart M. Nebulized formoterol fumarate: Dose selection and pharmacokinetics. Pulm Pharmacol Ther. 2008 Jul 8; [Epub ahead of print]

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
Respiration Disorders
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 May 16, 2013

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