NCT00163462已完成3 期
Comparison of Ciclesonide (80 mcg or 160 mcg Once Daily in the Evening) and Fluticasone Propionate (100 mcg Twice Daily in the Morning and Evening) in Pediatric Asthma Patients
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 750
- 试验地点
- 58
- 主要终点
- FEV1 absolute values
研究概览
简要总结
The aim of the study is to compare the efficacy of ciclesonide versus fluticasone propionate on lung function, symptoms, and use of rescue medication in children with persistent asthma. Ciclesonide will be inhaled once daily, using one of the two dose levels; fluticasone propionate will be inhaled at one dose level twice daily. The study duration consists of a baseline period (2 to 4 weeks) and a treatment period (12 weeks). The study will provide further data on safety and tolerability of ciclesonide.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 6 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Main Inclusion Criteria:
- •History of persistent bronchial asthma for at least 6 months
- •FEV1 50-90% of predicted
排除标准
- •Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
- •COPD (chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in lung function
- •Respiratory tract infection or asthma exacerbation within the last 30 days prior to entry into the study
- •History of life-threatening asthma
- •Premature birth
- •Current smoking
- •Smoking history with either equal or more than 10 pack-years
- •Pregnancy
- •Intention to become pregnant during the course of the study
- •Breast feeding
- •Lack of safe contraception
结局指标
主要结局
FEV1 absolute values
PD20FEV1 from methacholine challenge.
次要结局
- morning and evening PEF from diary
- PEF from spirometry
- salbutamol MDI use from diary
- laboratory investigation
- HPA-axis function assessed by free cortisol concentration in 24 hour-urine samples.
- asthma symptom score from diary
- diurnal PEF fluctuation from diary
- dropout rate due to asthma exacerbations and time to the first asthma exacerbation
- percentage of asthma symptom-free days, rescue medication-free days, nocturnal awakening free days and days on which patients perceived asthma control
- interview administered PAQLQ(S), self-administered PACQLQ
- physical examination and vital signs
- FEV1 as % of predicted
- onset of effect assessed by morning PEF, asthma total symptom score and use of rescue medication
- AEs
研究者
研究点 (58)
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