Comparison of School-Based Supervised Versus Parental Supervised Asthma Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00110383
Recruitment Status : Completed
First Posted : May 9, 2005
Last Update Posted : March 4, 2014
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:
University of Alabama at Birmingham

May 6, 2005
May 9, 2005
March 4, 2014
May 2004
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Asthma exacerbations [ Time Frame: Measured at 15 months ]
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Complete list of historical versions of study NCT00110383 on Archive Site
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Comparison of School-Based Supervised Versus Parental Supervised Asthma Therapy
Effectiveness of School Based Supervised Asthma Therapy
  1. Develop a simple school-based intervention using school-based supervised asthma therapy to increase adherence to asthma medication.
  2. Implement a school-based internet monitoring system within both the school-based supervised asthma therapy and parent supervised asthma therapy groups to record asthma symptoms, peak flow meter readings, school absences, and usage of rescue medications at school.
  3. Randomly assign 250 children from inner-city school systems to either school-based supervised asthma therapy or parental supervised asthma therapy.
  4. Compare children assigned to school-based supervised asthma therapy with children assigned to parent supervised asthma therapy, in regards to time-averaged proportion having at least one exacerbation per month, rescue medication use, peak flow meter readings, asthma symptoms, school absences, and asthma self-management knowledge.


Pediatric asthma is a well-documented public health issue in the United States. The impact of pediatric asthma can be measured by both health care costs and morbidity. Whereas many factors contribute to the high health care costs of asthma, much of the morbidity can be directly attributed to lack of adherence to medical treatments. The consequence of non-adherence for most individuals with ashtma is exacerbations. Greater numbers of exacerbations lead to increased school absenteeism, greater activity limitations, decreased quality of life for both parent and child, increased urgent health care use and costs, and increased parental days missed at work. Therefore, adherence to treatment is essential for proper asthma management and ultimate reductions in morbidity.

Asthma morbidity, as measured by the number of exacerbations, is largely preventable with patient education and optimal treatment. However, it has been demonstrated that patient education alone is insufficient to decrease asthma morbidity. Optimal treatment is essential to control asthma morbidity. Inhaled corticosteroids offer considerable protection against asthma exacerbations. However, only a minority of asthma patients take their inhaled steroids as recommended by the National Asthma Education and Prevention Program (NAEPP) guidelines. Therefore, the Pediatric Asthma Guidelines recommend development and testing of programs (including school-based programs) to increase adherence with therapy.

Because morbidity is higher in inner-city, low-income, minority children, this study will collaborate with several inner-city, low-income, minority school districts to examine the effects of school-based supervised asthma therapy.


This study is a longitudinal two-group trial of the effectiveness of a school-based supervised asthma therapy program. Two hundred and fifty children will be randomly assigned to one of two groups: school-based supervised asthma therapy or parental supervised asthma therapy. The children will be followed for 16 months.

Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Behavioral: School-Based Supervised Asthma Therapy
Child's inhaled steroid use supervised daily at school
  • Experimental: 1
    Supervised therapy
    Intervention: Behavioral: School-Based Supervised Asthma Therapy
  • No Intervention: 2
    Inhaled steroid use as usual care
Gerald LB, Gerald JK, Gibson L, Patel K, Zhang S, McClure LA. Changes in environmental tobacco smoke exposure and asthma morbidity among urban school children. Chest. 2009 Apr;135(4):911-916. doi: 10.1378/chest.08-1869. Epub 2008 Nov 18.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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May 2007
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Inclusion Criteria:

  • Persistent asthma requiring daily controller medication
  • Enrolled at a participating elementary school
Sexes Eligible for Study: All
6 Years to 12 Years   (Child)
Contact information is only displayed when the study is recruiting subjects
United States
R01HL075043 ( U.S. NIH Grant/Contract )
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Lynn B. Gerald, PhD, MSPH, University of Alabama at Birmingham
University of Alabama at Birmingham
National Heart, Lung, and Blood Institute (NHLBI)
Study Chair: Lynn B. Gerald, PhD, MSPH University of Alabama Birmingham Lung Health Center
University of Alabama at Birmingham
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP