EUCTR2014-004915-35-DE进行中（未招募）1 期
A randomized, double blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple doses of inhaled QBW276 in patients with cystic fibrosis - Safety,pharmacokinetics and pharmacodynamics study of inhaledQBW276 in patients with cystic fibrosis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 16
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
入选标准
- •- Cohorts 1 and 2 = any genotype on any standard of care treatment
- •- Cohort 3 = F508del homozygotes on standard of care at that time
- •- FEV1 between 40 and 100%
- •- LCI2.5 = 8 if FEV1 is more than 80%
- •Other protocol-defined inclusion/exclusion criteria may apply.
- •Are the trial subjects under 18? no
- •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 56
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Adrenal or electrolyte abnormalities
- •- Lung transplant
- •- Autonomic dysfunction (e.g. recurrent episodes of fainting, palpitations, etc.)
- •Other protocol-defined inclusion/exclusion criteria may apply
研究者
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