EUCTR2014-003581-25-DE进行中（未招募）1 期
Anti-inflammatory pulmonal therapy of CF-patients with Amitriptyline and Placebo - Randomised, double-blind, placebo-controlled cohort trial
niversity Hospital Tuebingen0 个研究点目标入组 102 人开始时间: 2014年12月15日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 102
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
- •1.Cystic Fibrosis is verified;
- •2.Patient is older than 12 years;
- •3.Patients weight is more than 35 kg;
- •4.FEV1 is higher than 25% and lower than 100% (two times in 3 months);
- •5.The patients lung is colonised with bacteria;
- •6.No acute pulmonal illness is present;
- •7.Lung function testing is possible;
- •8.A full course of therapy is possible without any restrictions;
- •9.Informed consent is given.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 15
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 87
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1.FEV1 in screening and baseline differs more than 10%;
- •2.Clinicial detoriation is present (exacerbation symptoms);
- •3.Change of CRP of more than 50% in screening period;
- •4.Glaucoma, seizures, heart insufficiency or major depression is pre-sent;
- •5.Intravenous antibiotic treatment was necessary for the last 2 weeks prior to the trial;
- •6.High dose steroid therapy;
- •7.On-therapy of tobramycine in the last 2 weeks;
- •8.Involvement of the patient in another study;
- •9.Pregnancy.
研究者
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