NCT00215449

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
690

participants targeted

Target at P75+ for phase_3

Geographic Reach
1 country

68 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
Last Updated

November 11, 2010

Status Verified

January 1, 2009

First QC Date

September 13, 2005

Last Update Submit

November 10, 2010

Conditions

Keywords

Chronic Obstructive Pulmonary DiseaseCOPDformoterolformoterol fumarate

Outcome Measures

Primary Outcomes (1)

  • Measure of lung function

Secondary Outcomes (2)

  • Change in lung function, as well as vital signs

  • Physical Exam results, Adverse Event reporting, etc

Interventions

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Medical diagnosis of COPD
  • Current or prior history of cigarette smoking

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (68)

Research Site

Bessemer, Alabama, 35023, United States

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Birmingham, Alabama, 35209, United States

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Phoenix, Arizona, 85006-2666, United States

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Tuscon, Arizona, 85715, United States

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Tuscon, Arizona, 85723, United States

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Tuscon, Arizona, 85745, United States

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Buena Park, California, 90620, United States

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Encinitas, California, 92024, United States

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Huntington Beach, California, 92647, United States

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Los Angeles, California, 90048, United States

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Los Angeles, California, 90095, United States

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Mission Viejo, California, 92691, United States

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San Diego, California, 92120, United States

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Sepulveda, California, 91343, United States

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Stockton, California, 95207, United States

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Walnut Creek, California, 94598, United States

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Colorado Springs, Colorado, 80907, United States

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Denver, Colorado, 80206, United States

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Wheat Ridge, Colorado, 80033, United States

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Hartford, Connecticut, 06105, United States

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Waterbury, Connecticut, 06708, United States

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Bay Pines, Florida, 33744, United States

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Clearwater, Florida, 33765, United States

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DeLand, Florida, 32720, United States

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Tampa, Florida, 33607, United States

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Atlanta, Georgia, 30342, United States

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Blue Ridge, Georgia, 30513, United States

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Hines, Illinois, 60141, United States

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Normal, Illinois, 61761, United States

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Evansville, Indiana, 47714, United States

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Shawnee Mission, Kansas, 66216, United States

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Topeka, Kansas, 66606, United States

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Louisville, Kentucky, 40215, United States

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New Orleans, Louisiana, 70115, United States

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Slidell, Louisiana, 70461, United States

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Edina, Minnesota, 55438, United States

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Minneapolis, Minnesota, 55402, United States

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Minneapolis, Minnesota, 55407, United States

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Minneapolis, Minnesota, 55416, United States

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Rochester, Minnesota, 55905, United States

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Butte, Montana, 59701, United States

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Omaha, Nebraska, 68134, United States

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Papillion, Nebraska, 68046, United States

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Henderson, Nevada, 89014, United States

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Cherry Hill, New Jersey, 08003, United States

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Springfield, New Jersey, 07081, United States

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Albuquerque, New Mexico, 87108, United States

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Larchmont, New York, 10538, United States

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New Hyde Park, New York, 11040, United States

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Chapel Hill, North Carolina, 27599, United States

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Cincinnati, Ohio, 45219, United States

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Cincinnati, Ohio, 45220, United States

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Cincinnati, Ohio, 45231, United States

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Cincinnati, Ohio, 45241, United States

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Cincinnati, Ohio, 45245, United States

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Columbus, Ohio, 43215, United States

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Medford, Oregon, 97504, United States

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Portland, Oregon, 97213, United States

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Easton, Pennsylvania, 18045, United States

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Spartanburg, South Carolina, 29307, United States

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Austin, Texas, 78750, United States

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El Paso, Texas, 79902, United States

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Houston, Texas, 77024, United States

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Houston, Texas, 77030, United States

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San Antonio, Texas, 78229, United States

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Richmond, Virginia, 23225, United States

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Madison, Wisconsin, 53792, United States

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Milwaukee, Wisconsin, 53209, United States

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Related Publications (1)

  • 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.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Formoterol Fumarate

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAmines

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 22, 2005

Primary Completion

December 1, 2005

Study Completion

April 1, 2006

Last Updated

November 11, 2010

Record last verified: 2009-01

Locations