Asthma
Conditions
Keywords
Asthma, Pediatric, Formoterol Fumarate, Foradil
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.
Interventions
DRUGFormoterol Fumarate
Sponsors
Dey
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
5 Years to 11 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary: The primary efficacy outcome is measure of lung function. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary: Change in lung function will be examined as a secondary efficacy outcome, as well as vital signs, physical examination, adverse event reporting,etc. | — |
Countries
United States
Outcome results
None listed