NCT00117208已完成2 期
A Cross-Over Comparative Study of Inhaled Mannitol, Alone and in Combination With Daily rhDNase, in Children With Cystic Fibrosis
Syntara2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2005年11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
- 20
- 试验地点
- 2
- 主要终点
- FEV1 after 12 weeks of each of the following treatment regimens: *mannitol only *rhDNase only *mannitol + rhDNase
研究概览
简要总结
The purpose of this study is to determine the medium term efficacy and safety profile of inhaled mannitol, on its own and also as an additional therapy to rhDNase (pulmozyme). In particular, we will assess the impact on: lung function; airway inflammation; sputum microbiology; exacerbations; quality of life; adverse events; exercise tolerance; total costs of hospital and community care; and cost-effectiveness.
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
- None
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Known diagnosis of cystic fibrosis (sweat test or genotype)
- •Of either gender
- •Aged between 8 and 18 years
- •Have a baseline FEV1 of <70% of the predicted normal value
- •Currently taking rhDNase for at least 4 weeks
排除标准
- •Currently active asthma, uncontrolled hypertension, colonised with Burkholderia cepacia or MRSA
- •Listed for transplantation
- •Known intolerance to mannitol, rhDNase or bronchodilators
研究组 & 干预措施
3
Other
combination
干预措施: mannitol + pulmozyme (Drug)
1
Experimental
干预措施: mannitol (Drug)
2
Active Comparator
DNase daily for 12 weeks
干预措施: Dornase alpha (Drug)
结局指标
主要结局
FEV1 after 12 weeks of each of the following treatment regimens: *mannitol only *rhDNase only *mannitol + rhDNase
时间窗: 12 weeks
次要结局
- to compare mannitol to rhDNase on FVC(12 weeks)
- to assess whether the effects of mannitol are additive to rhDNase(12 weeks)
- to demonstrate that mannitol does not cause deterioration in airway inflammation(12 weeks)
- to assess whether mannitol reduces the bacterial load in the lung(12 weeks)
- to assess whether the effects of mannitol are beneficial to quality of life(12 weeks)
- to assess whether mannitol, or mannitol + rhDNase are cost-effective compared to rhDNase alone(12 weeks)
研究者
研究点 (2)
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