NCT01883284已完成不适用
Action of Epigenetic Modifiers in Cystic Fibrosis Treatment: ex Vivo Model of Nasal Epithelium of CF Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Mature CFTR protein percentage variation after in vitro epigenetics modifiers treatment
研究概览
简要总结
Epigenetic modifiers has been showed to rescue F508del-CFTR channel to apical membrane of epithelial cell lines. In this study, the investigators evaluate epigenetic modifiers effects firstly on CFTR rescue, then on secretion and synthesis of inflammatory factors (IL-8, LXA4 and SCGB1A1) and mucines (MUC5AC and MUC5B) in a dynamic epithelium model using an air-liquide interface culture of nasals cells from CF patients or controls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Xylocaine hypersensibility
- •Porphyria
- •severe hepatic failure
- •Severe cardiac failure
- •local anesthesic contra indication
- •Specific Control subject Exclusion Criteria:
- •respiratory disease
- •cystic fibrosis
- •acute infection < 6 weeks
- •on treatment
- •antibiotic treatment < 3 months
结局指标
主要结局
Mature CFTR protein percentage variation after in vitro epigenetics modifiers treatment
时间窗: 24 months
次要结局
- Mucin composition variations after epigenetic modifiers treatment(24 months)
- Pro-inflammatory cytokines number variations after epigenetic modifiers treatment(24 months)
- Anti-inflammatory cytokines number variations after epigenetic modifiers treatment(24 months)
研究者
研究点 (2)
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