A Study to Compare the Efficacy and Safety of Fluticasone Furoate Nasal Sprays (FFNS) 55 Microgram (mcg) and 110 mcg in Chinese Pediatric Subjects With Allergic Rhinitis (AR)

Summary

This Phase IV interventional study is a multi-center, randomized, double-blind, placebo-controlled parallel study to evaluate the efficacy and safety of FFNS110 mcg and 55 mcg once daily versus vehicle placebo aqueous nasal spray in chinese pediatric subjects ages 2 to 12 years with AR. This study comprises screening and run-in period (4 to14 days), double-blind treatment period (28 days) and follows up period (3 to7 days). Subjects entering the study will participate for maximum of 50 days, including five clinical visits and a follow-up contact. The study is planned to enroll approximately 360 subjects.

Timeline

Start

2015-09-30

Primary completion

2017-10-25

Completion

2017-10-25

Outcome

Met primary endpoint

registry analysis (other test); Placebo vs FF 55 µg QD; p <0.001; Mean Difference (Final Values) -1.23 (95% CI -1.68 to -0.78); ANCOVA NCT02424539 ↗

registry analysis (other test); Placebo vs FF 110 µg QD; p <0.001; Mean Difference (Final Values) -1.32 (95% CI -1.77 to -0.87); ANCOVA NCT02424539 ↗

Publications

• Background Zhang Y, Wei P, Chen B, Li X, Luo X, Chen X, Xiang M, Li L, Zhao S, Xiao X, Yang X, Chen J, Fu Y, Xiao S, Liu H, Cheng L, Yao H. Intranasal fluticasone furoate in pediatric allergic rhinitis: randomized controlled study. Pediatr Res. 2021 May;89(7):1832-1839. doi: 10.1038/s41390-020-01180-0. Epub 2020 Oct 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fluticasone Furoate	Other / unclassified	55 ug	Intranasal
Subject	Fluticasone Furoate	Other / unclassified	110 ug	Intranasal

Indications