A Single (Assessor)-Blind, Randomised, Three-period, Cross-over Study to Compare the Safety of Flutiform pMDI, Fluticasone pMDI, and Beclometasone Autohaler in Paediatric Subjects Aged 5 to Less Than 12 Years With Mild Persistent Asthma by Means of Knemometry
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- To show non-inferiority of flutiform pMDI 50/5 µg (2 puffs bid) versus fluticasone pMDI 50 µg (2 puffs bid) based on the mean lower leg growth rates.
研究概览
简要总结
Aim of the study is to investigate the short-term growth in children with asthma aged 5-11 years in treatment with fluticasone propionate / formoterol spray (flutiform®) 200/20 micrograms per day
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Flutiform 50/5 ug (2 puffs bid) pMDI
Flutiform 50/5 ug (2 puffs bid) pMDI
干预措施: Flutiform 50/5 ug (2 puffs bid) pMDI (Drug)
Fluticasone 50 ug (2puffs bid) pMDI
Fluticasone 50 ug (2puffs bid) pMDI
干预措施: Fluticasone 50 ug (2puffs bid) pMDI (Drug)
Beclometasone Autohaler 50 ug (2 puffs bid)
Active control
干预措施: Beclometasone Autohaler 50 ug (2 puffs bid) (Drug)
结局指标
主要结局
To show non-inferiority of flutiform pMDI 50/5 µg (2 puffs bid) versus fluticasone pMDI 50 µg (2 puffs bid) based on the mean lower leg growth rates.
时间窗: Change from baseline in growth rate during the each treatment and washout period which is 2 weeks
Lower leg length will be measured in the afternoon, between 13:00 and 19:00h. Each individual subject will have their knemometry measurements performed at the same time of day (+/- 1 hour).
次要结局
- To compare the safety of flutiform pMDI 50/5 µg (2 puffs bid) versus fluticasone pMDI 50 µg based on overnight urinary free cortisol (corrected for creatinine).(every two weeks for duration of study which is two months.)