Official Title: “School-Based Asthma Therapy: Stage 2 Effectiveness Study”

Past research has shown that childhood asthma can be effectively controlled by the use of preventative medications on a daily basis. However, children often have difficulty adhering to a daily medication regimen. This study will evaluate the effectiveness of a school-based medication administration program, combined with a program to reduce tobacco exposure in the home, at reducing asthma symptoms in children.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study

Study Primary Completion Date: June 2009

Asthma prevalence has steadily increased in the United States since the early 1980s, with infants and young children showing the largest increase. Children with persistent asthma may be able to effectively control their symptoms by taking preventative medication on a daily basis; however, poor medication adherence is a common problem, particularly among children in poor urban areas of the country. Preliminary research has shown that administering preventative asthma medications at school is an effective way to increase adherence. However, in preliminary studies, beneficial effects were seen only among children not exposed to environmental tobacco smoke (ETS) at home; more research is needed to confirm the benefit of a school-based program in children exposed to ETS. The purpose of this study is to assess the overall effectiveness of a school-based medication administration program combined with an ETS reduction program at reducing asthma symptoms in children. The study will also evaluate the program's cost-effectiveness and may serve as a model for improving asthma care for children in urban communities.

Participation in this study will last 1 year. The study will enroll children with mild to severe persistent asthma who are attending participating schools in the Rochester City School District. Participants will be randomly assigned to either a school-based medication administration program, in which they will receive asthma medication at school on a daily basis, or to usual care, in which they will receive regular medical care. At study entry, participants will undergo a saliva test to determine their level of tobacco smoke exposure; parents will complete standardized written surveys to assess tobacco usage. Participants who are exposed to tobacco smoke will take part in an ETS reduction program as well. This program will encourage smoking cessation among family members and will focus on reducing total household ETS exposure. It will consist of one 30-minute in-home counseling session a couple of weeks following study entry, and two 15-minute follow-up phone calls to provide support and reinforcement. Saliva tests and standardized questionnaires will be completed again at Month 2 and at the final study visit. Telephone surveys will be conducted on a monthly basis in between visits to assess asthma symptoms and levels of ETS exposure.

Intervention(s) in this Clinical Trial

• Behavioral: School-Based Administration of Asthma Medication
  • Administration of Flovent or Advair by the school nurse each day the child is in school. Parents in this arm are provided with Flovent or Advair for home use on days the child is not in school.
• Behavioral: ETS Reduction Program
  • Administration of Flovent or Advair by the school nurse each day the child is in school. Parents in this arm are provided with Flovent or Advair for home use on days the child is not in school. In addition, parents of children randomized to the treatment group who are exposed to smoke will be counseled by a motivational interviewer in order to reduce the child's exposure to environmental tobacco smoke.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • School-Based Administration of Asthma Medication
• Experimental: 2
  • ETS Reduction Program
• No Intervention: 3

Primary Measures

• Average number of symptom-free days during peak winter season
  • Time Frame: Measured from November to February of each year
    Safety Issue?: No

Secondary Measures

• Cost-effectiveness
  • Time Frame: Measured from Years 1 to 3
    Safety Issue?: No

Inclusion Criteria:

• Physician-diagnosed asthma (based on report from parent with confirmation from physician)
• Mild to severe persistent asthma (criteria based on NHLBI guidelines), as determined by 1 of the following 4 criteria:
• 1. Experiences asthma symptoms at least 2 days per week
• 2. Uses rescue medication at least 2 days per week
• 3. Experiences night-time asthma symptoms at least 2 days per month
• 4. Experienced at least 4 episodes of asthma during the past year that have lasted more than 1 day and affected sleep
• Attending school at a participating preschool or elementary school in the Rochester
• City School District
• Signed physician permission; the physician must agree with the need for a daily inhaled corticosteroid and must sign an authorization form (any child without a primary care provider will be offered assistance enrolling into a practice and may be included in the study if their new provider authorizes participation)

Exclusion Criteria:

• Inability to speak and understand either English or Spanish
• No access to a working phone for follow-up surveys (either at home or an easily accessible alternate home)
• Planning to leave the school district within 6 months of study entry
• Other significant medical conditions, including congenital heart disease, cystic fibrosis, or other chronic lung disease, that could interfere with the assessment of asthma-related outcome measures
• In foster care or other unstable living situation in which consent cannot be obtained from a guardian; guardians unable to read will not be excluded because all self-administered instruments will be given verbally

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 3 Years

Maximum Age for this Clinical Trial: 10 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Overall Clinical Trial Officials and Contacts

Jill S. Halterman, MD, MPH Principal Investigator University of Rochester  

Overall Contact: Kelly M. Conn, MPH 585-273-5693 kelly_conn@urmc.rochester.edu

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00296998

Study ID Number: 358

ClinicalTrials.gov Identifier: NCT00296998

Health Authority: United States: Federal Government