A Pilot Study Involving an Asthma Management Program for Inner-city Early Head Start Children

Phoenix Children's Hospital1 site in 1 country20 target enrollmentMarch 2008

ConditionsAsthma

DrugsBudesonide respules

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Asthma
Sponsor: Phoenix Children's Hospital
Enrollment: 20
Locations: 1
Primary Endpoint: FEV0.5
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 2008

End Date

January 2010

Last Updated

16 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Phoenix Children's Hospital

Eligibility Criteria

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.

Outcomes

Primary Outcomes

FEV0.5

Time Frame: 2 months and 6 months into study

Secondary Outcomes

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)