NCT01450774已完成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 Pmdi (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
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Lower leg growth rate measured by knemometry
研究概览
简要总结
This is a single centre, double-blind, double-dummy, randomised, single-centre, 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 ≤ 11 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 50/6µg
Experimental
干预措施: CHF 1535 50/6µg (Drug)
beclomethasone dipropionate 50µg + formoterol fumarate 6µg
Active Comparator
干预措施: beclomethasone dipropionate 50µg + formoterol fumarate 6µg (Drug)
结局指标
主要结局
Lower leg growth rate measured by knemometry
时间窗: after a 2 week treatment
次要结局
- 24-hour urinary free cortisol/creatinine levels(after a 2 week treatment period)
- Changes in pre-dose morning and evening PEF (L/min)(pre and after a 2 week treatment period)
研究者
研究点 (1)
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