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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00624429
• Other study ID #: 07-053
• Status: Unknown status
• Phase: Phase 4
• First received: February 15, 2008
• Last updated: September 17, 2009
• Start date: March 2008
• Est. completion date: January 2010

Study information

• Verified date: February 2009
• Source: Phoenix Children's Hospital
• Contact: Peggy Radford, MD
• Phone: 602-546-0985
• Email: pradfor[@]phoenixchildrens.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 20
• Est. completion date: January 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Months to 36 Months

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Budesonide respules
Budesonide respules 0.5 mg nebulized once a day for 4 months of the study.

Locations

Country	Name	City	State
United States	Phoenix Children's Hospital	Phoenix	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Phoenix Children's Hospital	AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FEV0.5		2 months and 6 months into study
Secondary	emergency room visits		number of visits from baseline to 2 months and 2 months to 6months of study
Secondary	behavior scores		measured at baseline, 2 months and 6 months
Secondary	number of asthma exacerbations from baseline to 2 months and 2 months to 6 months		6 months