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

Primary Purpose

Asthma

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Budesonide respules
Sponsored by
Phoenix Children's Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, Children

Eligibility Criteria

12 Months - 36 Months (Child)All SexesDoes not accept 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.

Sites / Locations

  • Phoenix Children's HospitalRecruiting

Outcomes

Primary Outcome Measures

FEV0.5

Secondary Outcome Measures

emergency room visits
behavior scores
number of asthma exacerbations from baseline to 2 months and 2 months to 6 months

Full Information

First Posted
February 15, 2008
Last Updated
September 17, 2009
Sponsor
Phoenix Children's Hospital
Collaborators
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00624429
Brief Title
A Pilot Study Involving an Asthma Management Program for Inner-city Early Head Start Children
Official Title
A Pilot Study Involving an Asthma Management Program for Inner-city Early Head Start Children
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Unknown status
Study Start Date
March 2008 (undefined)
Primary Completion Date
December 2009 (Anticipated)
Study Completion Date
January 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Phoenix Children's Hospital
Collaborators
AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, Children

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Budesonide respules
Other Intervention Name(s)
Pulmicort respules
Intervention Description
Budesonide respules 0.5 mg nebulized once a day for 4 months of the study.
Primary Outcome Measure Information:
Title
FEV0.5
Time Frame
2 months and 6 months into study
Secondary Outcome Measure Information:
Title
emergency room visits
Time Frame
number of visits from baseline to 2 months and 2 months to 6months of study
Title
behavior scores
Time Frame
measured at baseline, 2 months and 6 months
Title
number of asthma exacerbations from baseline to 2 months and 2 months to 6 months
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
36 Months
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peggy Radford, MD
Phone
602-546-0985
Email
pradfor@phoenixchildrens.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peggy Radford, MD
Organizational Affiliation
Phoenix Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Phoenix Children's Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peggy Radford, MD
Phone
602-546-0985
Email
pradfor@phoenixchildrens.com
First Name & Middle Initial & Last Name & Degree
Peggy Radford, MD

12. IPD Sharing Statement

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

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