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.

INTRODUCTION: 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. METHODS: 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. RESULTS: A total of 296 children aged 6-11 years with persistent asthma met the inclusion criteria: 184 received fluticasone propionate (FP), 47 received fluticasone propionate/salmeterol (FP/SAL) and 65 received budesonide/formoterol (BUD/FOR). The groups differed in age at initiation of inhaled therapy (p < 0.001) and duration of follow-up (p = 0.014). 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. CONCLUSION: In children aged 6-11 years with persistent asthma, no single controller therapy demonstrated clear superiority in preventing asthma exacerbations.