Recruiting

Asthma Management

Sponsor:

Phoenix Children's Hospital

Code:

NCT00624429

Conditions

Asthma

Eligibility Criteria

Sex: All

Age: 1 - 3

Healthy Volunteers: Not accepted

Interventions

Budesonide respules

Study Details

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.

Conditions

Asthma

Study ID

NCT00624429

Start date

Mar, 2008

Status verified date

Feb, 2009

Completion date

Jan, 2010

Anticipated

Primary completion date

Dec, 2009

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 3

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Budesonide respules

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

Primary outcome measure

  • FEV0.5 [ Time Frame: 2 months and 6 months into study ]

Central Contacts and Locations

Central contacts

Peggy Radford, MD

602-546-0985pradfor@phoenixchildrens.com

Locations

Phoenix Children's Hospital

Recruiting

Phoenix, Arizona, United States, 85016

Contacts

Peggy Radford, MD

602-546-0985pradfor@phoenixchildrens.com

Principal Investigator:

Peggy Radford, MD

More Information

Sponsor

Phoenix Children's Hospital

Last update posted

Sep 18, 2009

Last verified

Feb, 2009

Keywords

  • Asthma
  • Children

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Phoenix Children's Hospital on 2009-09-18.