NCT00543686已完成2 期
A Randomised Controlled Open-Label Phase IV Mono Centre Study to Compare the Response Profiles of Montelukast Versus Fluticasone in Children With Pre-School Asthma
Johann Wolfgang Goethe University Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2007年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The primary efficacy variable is the number of responders with a very good asthma symptom control defined as requiring no rapid acting beta agonist (RABA) between the 2. and 6th week of intervention (end of trial)
研究概览
简要总结
Explorative comparison of montelukast with inhaled steroids (fluticasone) to estimate responder profiles, in terms of symptom scores, rescue medication, increase of FEV1, in correlation to presence of allergy, bronchial hyperreactivity (PD20), exhaled NO, excretion of leukotrienes, response to RABA and laboratory parameters in patients with pre-school asthma i.e. asthma phenotypes.
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
- None
入排标准
- 年龄范围
- 4 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients age 4 -6 years
- •Diagnosis of mild intermittent bronchial asthma (Step I-II) in the past 6 - 12 months as stated by the investigator:
- •Use of inhaled beta-2-agonists < 1/week (max 3 puff /d)
- •Exacerbation-free interval > 4 weeks prior to visit 1
- •The written informed consent of parents after received written and oral information about the aim, purpose and risks of the study must be present
排除标准
- •Asthma severity ≥ Step 2
- •Severe concomitant diseases
- •Suspected non-compliance
- •age below 4 and age above 7 years
- •last study participation < 30 days
研究组 & 干预措施
1
Active Comparator
Montelukast
干预措施: Montelukast (Drug)
2
Active Comparator
Fluticasone
干预措施: Fluticasone (Drug)
结局指标
主要结局
The primary efficacy variable is the number of responders with a very good asthma symptom control defined as requiring no rapid acting beta agonist (RABA) between the 2. and 6th week of intervention (end of trial)
次要结局
- the number of patients requiring at least five times RABA between the 2. and 6th week, the number of patients with an increase of FEV1 7.5%, the symptom score, symptom free days, rescue medication, presence of allergy RAST > 2, concentration of eNO, PD20
研究者
研究点 (1)
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