D1.178 - Real-World Comparison of Inhaled Corticosteroid Monotherapy versus Fixed-Dose Inhaled Corticosteroid–Long-Acting Beta-2 Agonist Combinations in Children Aged 6–11 Years with Persistent Asthma

In children aged 6-11 years with persistent asthma, earlier use of inhaled corticosteroid (ICS)-long-acting beta-2 agonist combination therapies has become a topic of increasing interest in recent years; however, available evidence in this age group remains limited. This study aimed to compare ICS monotherapy, fixed-dose ICS/salmeterol, and fixed-dose ICS/formoterol therapies regarding asthma exacerbations requiring systemic corticosteroids.

This retrospective study included children aged 6-11 years with persistent asthma who were followed for at least 1 year while receiving regular inhaled therapy between January 2021 and August 2024. Patients classified as The Global Initiative for Asthma (GINA) steps 2-4 were grouped according to treatment with ICS monotherapy, fixed-dose ICS/salmeterol, or fixed-dose ICS/formoterol. Asthma exacerbations were assessed based on the need for systemic corticosteroids, emergency department visits, and/or hospitalization.

A total of 296 children aged 6-11 years with persistent asthma met the inclusion criteria 184 fluticasone propionate (FP), 47 fluticasone propionate/salmeterol (FP/SAL) and 65 budesonide/formoterol (BUD/FOR). Overall, 113 patients (38.2%) experienced at least one asthma exacerbation during follow-up, with no significant difference among FP, FP/SAL, and BUD/FOR groups (p = 0.93). Rates of emergency department visits and hospital admissions were also comparable between groups (p = 0.805 and p = 0.383, respectively), and no significant differences were found regarding systemic corticosteroid–requiring asthma exacerbations.

In children aged 6-11 years with persistent asthma, no single controller therapy demonstrated clear superiority in preventing asthma exacerbations.