NCT01658891撤回3 期
A SINGLE CENTRE, RANDOMISED, DOUBLE-BLIND, DOUBLE-DUMMY, 2-WAY CROSS OVER STUDY TO COMPARE SAFETY ASSESSED BY KNEMOMETRY AND URINARY CORTISOL MEASUREMENTS OF CHF1535 50/6 NEXThaler® (FIXED COMBINATION OF BECLOMETHASONE DIPROPIONATE AND FORMOTEROL FUMARATE) AND THE FREE COMBINATION OF LICENSED BECLOMETHASONE DIPROPIONATE AND FORMOTEROL FUMARATE IN ASTHMATIC CHILDREN ALREADY TREATED WITH INHALED CORTICOSTEROIDS
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Lower Leg Growth rate measured by Knemometry
研究概览
简要总结
single center, double-blind, double-dummy, 2-way cross over study in asthmatic children already treated with inhaled corticosteroids
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prepuberal male and female outpatients, ≥ 5 and < 12 years old in Tanner stadium I according to Investigator's assessment;
- •Clinical diagnosis of mild asthma during at least two months prior to screening visit;
- •Forced Expiratory Volume during the first second (FEV1) > 80% of predicted normal values at screening visit;
排除标准
- •Endocrinological diseases including growth impairment or other chronic diseases;
- •Any concomitant disease requiring additional treatment with topic or systemic glucocorticosteroids;
研究组 & 干预措施
CHF 1535 50/6 µg
Experimental
干预措施: combination of beclomethasone dipropionate 50µg + formoterol fumarate 6µg (Drug)
beclomethasone dipropionate 100µg + Formoterol fumarate 6µg
Active Comparator
干预措施: free combination of beclomethasone dipropionate 100µg + Formoterol fumarate 6µg (Drug)
结局指标
主要结局
Lower Leg Growth rate measured by Knemometry
时间窗: after 2 weeks of treatment
次要结局
- 24-hour urinary free cortisol/creatinine levels(after 2 weeks of treatment)
- Changes in pre-dose morning and evening PEF (L/min)(after 2 weeks of treatment)
研究者
研究点 (1)
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