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

Phoenix Children's Hospital

Status and phase: Unknown; Phase 4

Conditions: Asthma

Treatments: Drug: Budesonide respules

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00624429

07-053

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 12 to 36 months old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)