Study in Patients With COPD

COPD Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00215449
• Other study ID #: DL-059
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: November 10, 2010
• Est. completion date: April 2006

Study information

• Verified date: January 2009
• Source: Dey
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 690
• Est. completion date: April 2006
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• COPD

Intervention

Drug:
• Formoterol Fumarate

Locations

Country	Name	City	State
United States	Research Site	Albuquerque	New Mexico
United States	Research Site	Atlanta	Georgia
United States	Research Site	Austin	Texas
United States	Research Site	Bay Pines	Florida
United States	Research Site	Bessemer	Alabama
United States	Research Site	Birmingham	Alabama
United States	Research Site	Blue Ridge	Georgia
United States	Research Site	Buena Park	California
United States	Research Site	Butte	Montana
United States	Research Site	Chapel Hill	North Carolina
United States	Research Site	Cherry Hill	New Jersey
United States	Research Site	Cincinnati	Ohio
United States	Research Site	Cincinnati	Ohio
United States	Research Site	Cincinnati	Ohio
United States	Research Site	Cincinnati	Ohio
United States	Research Site	Cincinnati	Ohio
United States	Research Site	Clearwater	Florida
United States	Research Site	Colorado Springs	Colorado
United States	Research Site	Columbus	Ohio
United States	Research Site	DeLand	Florida
United States	Research Site	Denver	Colorado
United States	Research Site	Easton	Pennsylvania
United States	Research Site	Edina	Minnesota
United States	Research Site	El Paso	Texas
United States	Research Site	Encinitas	California
United States	Research Site	Evansville	Indiana
United States	Research Site	Hartford	Connecticut
United States	Research Site	Henderson	Nevada
United States	Research Site	Hines	Illinois
United States	Research Site	Houston	Texas
United States	Research Site	Houston	Texas
United States	Research Site	Huntington Beach	California
United States	Research Site	Larchmont	New York
United States	Research Site	Los Angeles	California
United States	Research Site	Los Angeles	California
United States	Research Site	Louisville	Kentucky
United States	Research Site	Madison	Wisconsin
United States	Research Site	Medford	Oregon
United States	Research Site	Milwaukee	Wisconsin
United States	Research Site	Minneapolis	Minnesota
United States	Research Site	Minneapolis	Minnesota
United States	Research Site	Minneapolis	Minnesota
United States	Research Site	Mission Viejo	California
United States	Research Site	New Hyde Park	New York
United States	Research Site	New Orleans	Louisiana
United States	Research Site	Normal	Illinois
United States	Research Site	Omaha	Nebraska
United States	Research Site	Papillion	Nebraska
United States	Research Site	Phoenix	Arizona
United States	Research Site	Portland	Oregon
United States	Research Site	Richmond	Virginia
United States	Research Site	Rochester	Minnesota
United States	Research Site	San Antonio	Texas
United States	Research Site	San Diego	California
United States	Research Site	Sepulveda	California
United States	Research Site	Shawnee Mission	Kansas
United States	Research Site	Slidell	Louisiana
United States	Research Site	Spartanburg	South Carolina
United States	Research Site	Springfield	New Jersey
United States	Research Site	Stockton	California
United States	Research Site	Tampa	Florida
United States	Research Site	Topeka	Kansas
United States	Research Site	Tuscon	Arizona
United States	Research Site	Tuscon	Arizona
United States	Research Site	Tuscon	Arizona
United States	Research Site	Walnut Creek	California
United States	Research Site	Waterbury	Connecticut
United States	Research Site	Wheat Ridge	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Dey

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure of lung function
Secondary	Change in lung function, as well as vital signs
Secondary	Physical Exam results, Adverse Event reporting, etc