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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Phoenix Children's Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
AstraZeneca
Information provided by:
Phoenix Children's Hospital
ClinicalTrials.gov Identifier:
NCT00624429
First received: February 15, 2008
Last updated: September 17, 2009
Last verified: February 2009
  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 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study Involving an Asthma Management Program for Inner-city Early Head Start Children

Resource links provided by NLM:


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:
    Drug: Budesonide respules
    Budesonide respules 0.5 mg nebulized once a day for 4 months of the study.
    Other Name: Pulmicort respules
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Peggy Radford MD, Phoenix Children's Hospital
ClinicalTrials.gov Identifier: NCT00624429     History of Changes
Other Study ID Numbers: 07-053
Study First Received: February 15, 2008
Last Updated: September 17, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Phoenix Children's Hospital:
Asthma
Children

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Budesonide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on July 09, 2014