Intranasal fluticasone furoate in pediatric allergic rhinitis: randomized controlled study

Intranasal corticosteroids are the most efficacious anti-inflammatory medications for allergic rhinitis (AR). However, the efficacy and safety of intranasal corticosteroids in children have not yet been subject to specific research in China. The aim of this study was to investigate the efficacy and safety of fluticasone furoate nasal spray (FFNS) in a Chinese pediatric population. In this phase 4 randomized, double-blind, placebo-controlled, multicenter study, pediatric AR patients aged 2–12 years were randomized 1:1:1, receiving either FFNS 55 µg or 110 µg or placebo. Electronic diary cards were completed to record symptoms, rescue medication use, and treatment compliance. Anterior rhinoscopy and overall response to therapy were evaluated and recorded. Patients treated with FFNS at either dose experienced a significantly greater reduction in daily reflective total nasal symptom score compared with placebo. This was maintained in a younger subset of patients (2–6 years). Drug-related adverse events occurred in <20% of patients in all groups. FFNS was well tolerated at both doses. This study demonstrates favorable efficacy and safety profiles for FFNS 55 µg or 110 µg in Chinese pediatric populations (2–12 years), supporting its use in clinical treatment for AR children, including younger children aged 2–6 years.