A pilot randomized trial of school-based administration of inhaled corticosteroids for at-risk children with asthma

Objective: To investigate whether high adherence to inhaled corticosteroids (ICS) among disadvantaged urban public school children on public insurance with persistent asthma is achievable by having school nurses administer morning doses on each day that school is in session. Design/methods: This was a pilot prospective randomized clinical trial of home versus school nurse-administered ICS among children on Medicaid enrolled in grades K-8. The primary outcome was the proportion of expected morning doses of ICS given to the intervention group in school over the 60-day treatment period. Secondary outcomes included the relative proportions of expected doses (morning, evening, and total), asthma-related morbidity, quality of life, and health-care utilization. Results: A total of 46 patients were enrolled (mean age 8.21 +/- 2.45; 56.5% male; 91.3% non-Hispanic, African-Americans), and follow-up data were available for 44/46 (95.7%) patients. The groups did not differ in age, gender, race/ethnicity, or asthma severity. The intervention group received 91.7% of expected morning doses of ICS at school over the 60-day treatment period (95% CI [87.7, 95.5]). Intervention patients reported significantly less functional limitation (42.9% vs. 73.9%, p = 0.04), adjustment to family life (23.8% vs. 56.5%, p = 0.03), and sleep loss (1.7 vs. 4.1 nights in last 2weeks, p = 0.035) than control patients at the end of the 60-days study period. There were no differences in unscheduled health-care utilization by group. Conclusions: These pilot data suggest that school-based administration of ICS has the potential to achieve high adherence to morning doses of ICS on school days among urban, disadvantaged, and largely minority children with asthma.