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

This study is currently recruiting participants.

Verified by Phoenix Children's Hospital, February 2009

First Received: February 15, 2008 Last Updated: February 3, 2009 History of Changes

Sponsors and Collaborators:	Phoenix Children's Hospital AstraZeneca
Information provided by:	Phoenix Children's Hospital
ClinicalTrials.gov Identifier:	NCT00624429

Purpose

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.

Condition	Intervention	Phase
Asthma	Drug: Budesonide respules	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Efficacy Study
Official Title:	A Pilot Study Involving an Asthma Management Program for Inner-City Early Head Start Children

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Budesonide

U.S. FDA Resources

Further study details as provided by Phoenix Children's Hospital:

Primary Outcome Measures:

FEV0.5 [ Time Frame: 2 months and 6 months into study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

emergency room visits [ Time Frame: number of visits from baseline to 2 months and 2 months to 6months of study ] [ Designated as safety issue: No ]
behavior scores [ Time Frame: measured at baseline, 2 months and 6 months ] [ Designated as safety issue: No ]
number of asthma exacerbations from baseline to 2 months and 2 months to 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	March 2008
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Intervention Details:

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

Eligibility

Ages Eligible for Study:	12 Months to 36 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00624429

Contacts

Contact: Peggy Radford, MD

602-546-0985

pradfor@phoenixchildrens.com

Locations

United States, Arizona
Phoenix Children's Hospital	Recruiting
Phoenix, Arizona, United States, 85016
Contact: Peggy Radford, MD 602-546-0985 pradfor@phoenixchildrens.com
Principal Investigator: Peggy Radford, MD

Sponsors and Collaborators

Phoenix Children's Hospital

AstraZeneca

Investigators

Principal Investigator:

Peggy Radford, MD

Phoenix Children's Hospital

More Information

No publications provided

Responsible Party:	Phoenix Children's Hospital ( Peggy Radford MD )
Study ID Numbers:	07-053
Study First Received:	February 15, 2008
Last Updated:	February 3, 2009
ClinicalTrials.gov Identifier:	NCT00624429 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Phoenix Children's Hospital:

Asthma
Children

Study placed in the following topic categories:

Anti-Inflammatory Agents
Bronchial Diseases
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Budesonide
Asthma
Anti-Asthmatic Agents
Hormones
Glucocorticoids

Lung Diseases, Obstructive
Hypersensitivity
Respiratory Tract Diseases
Lung Diseases
Hypersensitivity, Immediate
Peripheral Nervous System Agents
Bronchodilator Agents
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Bronchial Diseases
Immune System Diseases
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Budesonide
Anti-Asthmatic Agents
Asthma
Hormones
Glucocorticoids

Pharmacologic Actions
Lung Diseases, Obstructive
Hypersensitivity
Respiratory Tract Diseases
Autonomic Agents
Therapeutic Uses
Lung Diseases
Hypersensitivity, Immediate
Peripheral Nervous System Agents
Bronchodilator Agents
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on September 04, 2009