NCT00215371
Completed
Phase 2
Study in Patients With Asthma
Dey1 site in 1 country32 target enrollmentJuly 2002
ConditionsAsthma
DrugsFormoterol Fumarate
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Asthma
- Sponsor
- Dey
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Primary: The primary efficacy outcome is measure of lung function.
- Status
- Completed
- Last Updated
- 15 years ago
Overview
Brief Summary
The purpose of this study is to determine which dose of the investigational drug is safest and most effective compared to the control group.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Require the regular use of an inhaled beta-2-selective adrenergic agent.
- •No clinically significant abnormalities on the medical history, physical examination, and clinical laboratory tests.
Exclusion Criteria
- •Active acute or chronic disorders of the respiratory system within one month prior to screening.
- •Smoking history within the past 12 months or greater than a lifetime 10 pack-year smoking history.
- •Debilitating systemic and/or life-threatening diseases.
Outcomes
Primary Outcomes
Primary: The primary efficacy outcome is measure of lung function.
Secondary Outcomes
- Secondary: Change in lung function will be examined as a secondary efficacy outcome, as well as vital signs, physical examination, adverse event reporting,etc.
Study Sites (1)
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