Intranasal fluticasone furoate in pediatric allergic rhinitis: randomized controlled study

Background 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. Methods 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 mu g or 110 mu g 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. Results 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 Conclusions This study demonstrates favorable efficacy and safety profiles for FFNS 55 mu g or 110 mu g in Chinese pediatric populations (2-12 years), supporting its use in clinical treatment for AR children, including younger children aged 2-6 years. Impact The aim of this study was to investigate the efficacy and safety of intranasal fluticasone furoate in Chinese pediatric allergic rhinitis. This research not only addresses the deficiency in efficacy and safety data for intranasal corticosteroids in very young patients (aged 2-6 years) worldwide but also demonstrates that fluticasone furoate nasal spray shows a favorable benefit/risk profile at different dose levels. Our data will be of interest to the broad readership of and will positively contribute to the dialog regarding the treatment of allergic rhinitis in children aged 2-6 years.

Automated summary

This study demonstrates the favorable efficacy and safety of fluticasone furoate nasal spray in Chinese pediatric allergic rhinitis patients, supporting its clinical use in treating children, including younger children aged 2-6 years. This research not only fills the gap in efficacy and safety data for intranasal corticosteroids in very young patients worldwide, but also shows a beneficial risk/benefit profile at different dosage levels. Our findings will be of interest to a broad readership and contribute positively to discussions on allergic rhinitis treatment in children aged 2-6 years.