Safety and efficacy of fluticasone furoate nasal spray in Japanese children 2 to <15 years of age with perennial allergic rhinitis: a multicentre, open-label trial.

Background: Fluticasone furoate nasal spray (FFNS) is a glucocorticoid developed for the treatment of allergic rhinitis (AR). This study aimed to assess the safety, efficacy, and systemic exposure of FFNS in Japanese children with perennial AR (PAR).

Methods: In this multicentre, open-label, phase 3 study, 61 children aged 2 to <15 years were treated with FFNS 55 μg, once daily for 12 weeks.

Efficacy and safety of fluticasone furoate nasal spray in Japanese children with perennial allergic rhinitis: a multicentre, randomized, double-blind, placebo-controlled trial.

Background: Fluticasone furoate nasal spray (FFNS) is a glucocorticoid developed for the treatment of allergic rhinitis (AR). This is the first randomized clinical trial to assess the efficacy and safety of FFNS in Japanese children with perennial AR (PAR).

Methods: In this multicentre, randomized, double-blind, placebo-controlled, parallel-group, phase III study, 261 children aged 6 to <15 years were treated with FFNS 55μg, once daily or placebo for two weeks.

Comparison of levocetirizine pharmacokinetics after single doses of levocetirizine oral solution and cetirizine dry syrup in healthy Japanese male subjects.

Objective: Levocetirizine, the R-enantiomer of cetirizine, is classified as a second generation antihistamine used for the treatment of allergic disorders. This study aimed to compare exposure to levocetirizine when given as levocetirizine oral solution (OS) 5 mg to that when given as cetirizine dry syrup (DS) 10 mg, which contains equal proportions of levocetirizine and dextrocetirizine, in healthy Japanese male subjects.

Methods: The study was conducted in an open-label, single dose, randomized and two-way cross-over design.