A Pilot Study Involving an Asthma Management Program for Inner-city Early Head Start Children
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 asthma
Started Mar 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 15, 2008
CompletedFirst Posted
Study publicly available on registry
February 27, 2008
CompletedStudy Start
First participant enrolled
March 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedSeptember 18, 2009
February 1, 2009
1.8 years
February 15, 2008
September 17, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
FEV0.5
2 months and 6 months into study
Secondary Outcomes (3)
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
Interventions
Budesonide respules 0.5 mg nebulized once a day for 4 months of the study.
Eligibility Criteria
You may qualify if:
- Children 12-36 months of age with a history of wheezing or airway reactivity responding to bronchodilators, or diagnosed with asthma by a physician.
You may not qualify if:
- Children less than 12 months or greater than 36 months of age.
- Children diagnosed with attention deficit disorder by a physician or psychologist.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Phoenix Children's Hospitallead
- AstraZenecacollaborator
Study Sites (1)
Phoenix Children's Hospital
Phoenix, Arizona, 85016, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peggy Radford, MD
Phoenix Children's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 15, 2008
First Posted
February 27, 2008
Study Start
March 1, 2008
Primary Completion
December 1, 2009
Study Completion
January 1, 2010
Last Updated
September 18, 2009
Record last verified: 2009-02