Study in Patients With COPD

NCT ID: NCT00215449

Last Updated: 2010-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

690 participants

Study Classification

INTERVENTIONAL

Study Completion Date

2006-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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COPD

Keywords

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Chronic Obstructive Pulmonary Disease COPD formoterol formoterol fumarate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Formoterol Fumarate

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dey

INDUSTRY

Sponsor Role lead

Responsible Party

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Dey

Locations

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Research Site

Bessemer, Alabama, United States

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Birmingham, Alabama, United States

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Phoenix, Arizona, United States

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Tuscon, Arizona, United States

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Tuscon, Arizona, United States

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Tuscon, Arizona, United States

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Buena Park, California, United States

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Encinitas, California, United States

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Huntington Beach, California, United States

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Los Angeles, California, United States

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Los Angeles, California, United States

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Mission Viejo, California, United States

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San Diego, California, United States

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Sepulveda, California, United States

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Stockton, California, United States

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Walnut Creek, California, United States

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Colorado Springs, Colorado, United States

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Denver, Colorado, United States

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Wheat Ridge, Colorado, United States

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Hartford, Connecticut, United States

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Waterbury, Connecticut, United States

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Bay Pines, Florida, United States

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Clearwater, Florida, United States

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DeLand, Florida, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Blue Ridge, Georgia, United States

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Hines, Illinois, United States

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Normal, Illinois, United States

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Evansville, Indiana, United States

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Shawnee Mission, Kansas, United States

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Topeka, Kansas, United States

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Louisville, Kentucky, United States

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New Orleans, Louisiana, United States

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Slidell, Louisiana, United States

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Edina, Minnesota, United States

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Minneapolis, Minnesota, United States

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Minneapolis, Minnesota, United States

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Minneapolis, Minnesota, United States

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Rochester, Minnesota, United States

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Butte, Montana, United States

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Omaha, Nebraska, United States

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Papillion, Nebraska, United States

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Henderson, Nevada, United States

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Cherry Hill, New Jersey, United States

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Springfield, New Jersey, United States

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Albuquerque, New Mexico, United States

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Larchmont, New York, United States

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New Hyde Park, New York, United States

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Chapel Hill, North Carolina, United States

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Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Columbus, Ohio, United States

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Medford, Oregon, United States

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Portland, Oregon, United States

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Easton, Pennsylvania, United States

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Spartanburg, South Carolina, United States

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Austin, Texas, United States

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El Paso, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Richmond, Virginia, United States

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Madison, Wisconsin, United States

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Milwaukee, Wisconsin, United States

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Countries

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United States

References

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Donohue JF, Hanania NA, Fogarty C, Campbell SC, Rinehart M, Denis-Mize K. Long-term safety of nebulized formoterol: results of a twelve-month open-label clinical trial. Ther Adv Respir Dis. 2008 Aug;2(4):199-208. doi: 10.1177/1753465808093934.

Reference Type RESULT
PMID: 19124372 (View on PubMed)

Other Identifiers

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DL-059

Identifier Type: -

Identifier Source: org_study_id