Intranasal fluticasone furoate in pediatric allergic rhinitis: randomized controlled study

Yamei Zhang, Ping Wei, Bobei Chen, Xiaoyan Li, Xianyang Luo, Xianming Chen, Mingliang Xiang, Lan Li, Sijun Zhao, Xuping Xiao, Xinmin Yang, Jie Chen, Yong Fu, Shuifang Xiao, Haixia Liu, Lei Cheng, Hongbing Yao, Yamei Zhang, Ping Wei, Bobei Chen, Xiaoyan Li, Xianyang Luo, Xianming Chen, Mingliang Xiang, Lan Li, Sijun Zhao, Xuping Xiao, Xinmin Yang, Jie Chen, Yong Fu, Shuifang Xiao, Haixia Liu, Lei Cheng, Hongbing Yao

Abstract

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 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.

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 <20% of patients in all groups. FFNS was well tolerated at both doses.

Conclusions: 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.

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 Pediatric Research and will positively contribute to the dialog regarding the treatment of allergic rhinitis in children aged 2-6 years.

Trial registration: ClinicalTrials.gov NCT02424539.

Conflict of interest statement

The authors declare no competing interests.

Figures

Fig. 1. Study design.
Fig. 1. Study design.
FFNS fluticasone furoate nasal spray, R randomization.
Fig. 2. Mean change from baseline in…
Fig. 2. Mean change from baseline in daily rTNSS (ITT population).
FFNS fluticasone furoate nasal spray, ITT intent to treat, rTNSS reflective total nasal symptom scores. Data are presented for the entire treatment period and were statistically significant (P < 0.001) over 2 and 4 weeks for all dose variations when compared with placebo.

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Source: PubMed

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