Asthma
Conditions
Keywords
Asthma, Children
Brief summary
The Early Head Start program serves lower socioeconomic inner-city children from birth to 3 years. This population has a higher incidence of asthma due to increased exposures. The primary objective of this study is: To evaluate the effect of early identification of these high risk, inner-city asthmatic infants, age 1-3 years, and early treatment with pulmicort respules on asthma morbidity (asthma symptoms and use of rescue medications), infant pulmonary functions, and use of health care resources (unscheduled clinic visits, emergency room visits and hospitalizations). To obtain pilot behavior information using Carey Temperament Scale, Bitsea and expand to Itsea if indicated.
Interventions
Budesonide respules 0.5 mg nebulized once a day for 4 months of the study.
Sponsors
AstraZeneca
Phoenix Children's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Months to 36 Months
Healthy volunteers
No
Inclusion criteria
* Children 12-36 months of age with a history of wheezing or airway reactivity responding to bronchodilators, or diagnosed with asthma by a physician.
Exclusion criteria
* Children less than 12 months or greater than 36 months of age. * Children diagnosed with attention deficit disorder by a physician or psychologist.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| FEV0.5 | 2 months and 6 months into study |
Secondary
| Measure | Time frame |
|---|---|
| emergency room visits | number of visits from baseline to 2 months and 2 months to 6months of study |
| behavior scores | measured at baseline, 2 months and 6 months |
| number of asthma exacerbations from baseline to 2 months and 2 months to 6 months | 6 months |
Countries
United States
Contacts
Primary ContactPeggy Radford, MD
Outcome results
None listed