NCT00163449已完成3 期
BALLOON: Efficacy and Safety - Study by ALTANA on Ciclesonide in Pre-school Asthma Patients
适应症
干预措施
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
- 1,000
- 试验地点
- 1
- 主要终点
- time to first moderate or severe asthma exacerbation.
研究概览
简要总结
The aim of the present study is to compare the efficacy of inhaled ciclesonide in pre-school children. Ciclesonide will be inhaled once daily, using one of three dose levels and tested versus placebo. The study duration consists of a baseline period (2 to 4 weeks) and a treatment period (24 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
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 2 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent by the parents or legal guardians of the patient
- •Outpatients
- •Good health with the exception of asthma
- •Documented diagnosis of asthma for more than 6 months
- •Use of rescue medication only or pretreatment with a controller drug
排除标准
- •Concomitant severe diseases
- •Diseases contraindicated for the use of inhaled steroids
- •Other relevant lung diseases causing impairment in pulmonary function
- •Recurrent, episodic wheezing only
- •History of life-threatening asthma
- •History of any mechanical ventilation
- •Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation
- •Premature birth (< 32 weeks gestation)
研究组 & 干预措施
1
Active Comparator
Ciclesonide 40 µg
干预措施: Ciclesonide (Drug)
2
Active Comparator
Ciclesonide 80 µg
干预措施: Ciclesonide (Drug)
3
Active Comparator
Ciclesonide 160 µg
干预措施: Ciclesonide (Drug)
4
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
time to first moderate or severe asthma exacerbation.
时间窗: 24 weeks
次要结局
- adverse events(24 weeks)
- vital signs(24 weeks)
- serum cortisol(24 weeks)
- urine cortisol variables(24 weeks)
- physical examination(24 weeks)
- rate of patients with moderate or severe asthma exacerbation(24 weeks)
- rate of patients with moderate asthma exacerbation(24 weeks)
- time to first moderate asthma exacerbation(24 weeks)
- morning and evening PEF from diary(24 weeks)
- laboratory work-up(24 weeks)
- rate of patients with severe asthma exacerbation(24 weeks)
- time to first severe asthma exacerbation(24 weeks)
- asthma symptom score from diary(24 weeks)
- use of rescue medication(24 weeks)
- patient perceived asthma control(24 weeks)
- quality of life data (PACQLQ)(24 weeks)
- pulmonary function variables measured at the investigational sites(24 weeks)
- body growth determined by stadiometry.(24 weeks)
研究者
研究点 (1)
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