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NCT00215423 Clinical Trial

Study in Patients With COPD

Chronic Obstructive Pulmonary Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00215423
Other study ID # DL-057
Secondary ID
Status Completed
Phase Phase 2
First received September 13, 2005
Last updated November 10, 2010
Est. completion date September 2005

Study information
Verified date August 2008
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 which dose of the investigational drug is the most safe and effective for the treatment of COPD compared to the control drug

Recruitment information / eligibility
Status Completed
Enrollment 49
Est. completion date September 2005
Est. primary completion date December 2003
Accepts healthy volunteers No
Gender Both
Age group 5 Years to 70 Years
Eligibility 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)

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• Formoterol Fumarate

Locations
Country Name City State
United States Research Site Butte Montana
United States Research Site Hines Illinois
United States Research Site Medford Oregon
United States Research Site Omaha Nebraska
United States Research Site Phoenix Arizona
United States Research Site Shawnee Mission Kansas
United States Research Site Wheat Ridge Colorado

Sponsors (1)
Lead Sponsor Collaborator
Dey

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 Oct;21(5):818-23. doi: 10.1016/j.pupt.2008.07.002. Epub 2008 Jul 8. — 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
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