Dataset from Study HZA114971, A Multicentre Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Effects of a One-Year Regimen of Orally Inhaled Fluticasone Furoate 50 mcg Once Daily on Growth Velocity in Prepubertal, Paediatric Subjects With Asthma

There is a regulatory requirement to evaluate the extent of reduction (if any) of growth
velocity associated with inhaled corticosteroid (ICS) containing products that are to be
administered to children, and to this end there is Food and Drug Administration (FDA)
regulatory guidance. This is a randomised, single-blind (run-in period)/double-blind
(treatment period), parallel group, placebo controlled, multicentre study to assess the
effect of once daily (OD) inhaled fluticasone furoate (FF) 50 microgram (mcg) on growth
velocity in prepubertal asthmatic children on a background therapy of open-label montelukast.
This study will be conducted over a total duration of approximately 76 weeks: 16-week run-in
period (single-blind placebo inhaler), 52-week double-blind treatment period (inhaled FF 50
mcg /placebo administered OD in the morning for 52 weeks) and 8-week follow-up period. The
purpose of the study is to evaluate the magnitude of effect (with a level of precision) on
growth velocity of prepubertal asthmatic paediatric subjects (aged 5 to <9 years) following
administration of OD inhaled FF 50 mcg for one year. This study fulfills European Union (EU)
and United States (US) regulatory requirements for the evaluation of potential growth
suppression in children.

针对拟用于儿童的含吸入性糖皮质激素（inhaled corticosteroid, ICS）制剂，现有监管要求需评估其可能引发的生长速率降低程度（若存在）；为此，美国食品药品监督管理局（Food and Drug Administration, FDA）发布了相关监管指南。本研究为一项随机、单盲（导入期）/双盲（治疗期）、平行组设计、安慰剂对照的多中心临床试验，旨在评估每日一次（once daily, OD）吸入用糠酸氟替卡松（fluticasone furoate, FF）50微克（microgram, mcg）对接受开放标签孟鲁司特背景治疗的青春期前哮喘儿童生长速率的影响。本研究总持续时长约76周，分为三个阶段：16周导入期（单盲安慰剂吸入剂给药）、52周双盲治疗期（每日晨起吸入FF 50 mcg或安慰剂，持续52周）以及8周随访期。本研究的核心目的为，评估每日一次吸入FF 50 mcg给药持续一年后，对年龄5至<9岁的青春期前哮喘儿科受试者生长速率的影响效应大小（附带精度水平）。本研究符合欧盟（European Union, EU）与美国（United States, US）针对儿童潜在生长抑制评估的监管要求。