EUCTR2006-006693-24-IT进行中（未招募）不适用
A randomized, double blind, placebo controlled, dose-finding study to evaluate the efficacy and safety of aerosolized Moli1901 in adolescents (12 years of age or older) and adults with cystic fibrosis - ND
AOP ORPHAN PHARMACEUTICALS0 个研究点目标入组 160 人开始时间: 2007年11月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 160
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male or female subject of 12 years age of older BMI > = -2 SDS for 12-19 years old patients and > = 18.5 for adults (20 years or older) Confirmed diagnosis of cystic fibrosis Screening FEV1 between 50 and 85% of predicted Oxigen saturation level > 90% Informed consent
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Bronchial hyperresponsiveness Evidence of instable lung function Pulmonary diseases such as pneumonia, tubercolosis or lung cancer Acute upper respiratory tract infection within the last 2 weeks Acute lower respiratory tract infection within the last 4 weeks Pulmonary exacerbation within the last 4 weeks Any treatment via ''on-off'' regimen in the last 6 weeks or planned Poorly controlled diabetes mellitus Women of childbearing potential refusing effective contraception, or pregnant or lactating
研究者
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