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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00215384
Other study ID # DL-052
Secondary ID
Status Completed
Phase Phase 2
First received September 13, 2005
Last updated November 10, 2010
Est. completion date October 2005

Study information

Verified date February 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 compared to the control drug.


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date October 2005
Est. primary completion date April 2003
Accepts healthy volunteers No
Gender Both
Age group 50 Years and older
Eligibility Inclusion Criteria:

-History of COPD and cigarette smoking

Exclusion Criteria:

- Clinical diagnosis of asthma.

- Chest X-ray that is diagnostic of a significant pulmonary disease other than COPD

- Disease of other major organ systems

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 Denver Colorado
United States Research Site Hines Illinois
United States Research Site Los Angeles California
United States Research Site Medford Oregon
United States Research Site Missoula Montana
United States Research Site Tacoma Washington
United States Research Site Upland California

Sponsors (1)

Lead Sponsor Collaborator
Dey

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary The primary outcome variable is the measure of lung function.
Secondary Change in lung function will be examined as a secondary outcome, as well as vital signs, physical examination, adverse even reporting, etc.
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