跳至主要内容
临床试验/NCT03999242
NCT03999242已完成不适用

Clinical Significance of Charcot-Leyden Crystals in Bronchial and Sinonasal Pathological Samples

University Hospital, Montpellier1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2019年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
1
主要终点
'Level of asthma control/severity according to GINA stepwise approach

研究概览

简要总结

Charcot Leyden crystals (CLC) are sometime reported in pathological reports of airway or sinonasal samples but their clinical significance remain elusive. The investigators organized a retrospective analysis of all consecutive patients with CLC seen at our institution between 1986 and 2019

详细描述

In recent years, improved knowledge of eosinophilic inflammation has led to the approval of biologics aimed at inhibiting the pathways of eosinophilic activation, notably via the interleukin 5 pathway in eosinophilic asthmatic patients uncontrolled despite receiving maximum doses of standard drugs. These treatments showed efficacy in asthmatic patients with a high level of eosinophils in their induced sputum (> 3%) and the criteria were extended to those with circulating eosinophilia (> 300 / mm3). Eosinophils are therefore an important biomarker for phenotyping asthmatic patients. The Charcot-Leyden crystals are a reflection of the presence of eosinophils, and are sometimes found in some pathological samples. It is hypothesized that the presence of Charcot-Leyden crystals, a reflection of tissue eosinophilia, is a predictive factor for the efficacy of anti-IL5 biotherapies in patients with severe eosinophilic asthma.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Having Charcot Leyden Crystals in a pathological sample

排除标准

  • Having Charcot Leyden Crystals in a pathological sample taken outside the airways the nose and the sinus

结局指标

主要结局

'Level of asthma control/severity according to GINA stepwise approach

时间窗: Baseline (day 0) to Month 12

次要结局

  • Cumulative annualized dose of inhaled and systemic corticosteroids(Baseline (day 0) to Month 12)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验