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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2009 by Phoenix Children's Hospital.
Recruitment status was:  Recruiting
Information provided by:
Phoenix Children's Hospital Identifier:
First received: February 15, 2008
Last updated: September 17, 2009
Last verified: February 2009

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
Drug: Budesonide respules
Phase 4

Study Type: Interventional
Study Design: 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 ]

Secondary Outcome Measures:
  • emergency room visits [ Time Frame: number of visits from baseline to 2 months and 2 months to 6months of study ]
  • behavior scores [ Time Frame: measured at baseline, 2 months and 6 months ]
  • number of asthma exacerbations from baseline to 2 months and 2 months to 6 months [ Time Frame: 6 months ]

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

Ages Eligible for Study:   12 Months to 36 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier: NCT00624429

Contact: Peggy Radford, MD 602-546-0985

United States, Arizona
Phoenix Children's Hospital Recruiting
Phoenix, Arizona, United States, 85016
Contact: Peggy Radford, MD    602-546-0985   
Principal Investigator: Peggy Radford, MD         
Sponsors and Collaborators
Phoenix Children's Hospital
Principal Investigator: Peggy Radford, MD Phoenix Children's Hospital
  More Information

Responsible Party: Peggy Radford MD, Phoenix Children's Hospital Identifier: NCT00624429     History of Changes
Other Study ID Numbers: 07-053
Study First Received: February 15, 2008
Last Updated: September 17, 2009

Keywords provided by Phoenix Children's Hospital:

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Hormones, Hormone Substitutes, and Hormone Antagonists processed this record on April 28, 2017