Asthma
Conditions
Keywords
Asthma, Formoterol, Fumarate
Brief summary
The purpose of this study is to determine the most safe and effective dose of the investigational drug in comparison with a control drug and placebo.
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 12 Years
Healthy volunteers
No
Inclusion criteria
* Children with a history of asthma * Written guardian approval
Exclusion criteria
* Current or recent asthma exacerbation, requiring hospitalization * History of smoking * Debilitating or systemic and/or life-threatening diseases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measure of lung function | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in lung function, as well as vital signs | — |
| Physical Exam results, AE reporting, etc | — |
Countries
United States
Outcome results
None listed