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临床试验/NCT05364996
NCT05364996招募中不适用

Cross-sectional Pilot Study of the Alveolar and Serum sRAGE Biomarker in Severe Asthma in Children.

University Hospital, Clermont-Ferrand1 个研究点 分布在 1 个国家目标入组 85 人开始时间: 2022年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
85
试验地点
1
主要终点
alveolar sRAGE level

研究概览

简要总结

sRAGE is a recognized marker of alveolar injury in acute respiratory distress syndrome (ARDS). More recently, it seems to be an interesting marker in asthma. It is the soluble form of the pro-inflammatory RAGE receptor overexpressed in the lungs and in particular the bronchi. It acts as a decoy to its ligands, and thus blocks the pro-inflammatory axis of RAGE.

Few studies are available in asthma, especially in children. A local study showed low levels of serum sRAGE in the context of acute bronchiolitis. The same finding emerges from the few studies available in asthma, with rates all the lower when the asthma is poorly controlled. A study carried out in the animal model in 2012 found an absence of inflammatory infiltrate, the absence of increased expression of mucin and the absence of mucus goblet cell hyperplasia within the respiratory epithelium in the absence of RAGE receptor in sensitized mice dust mites, after exposure to their allergen. One could imagine in the long term a potential therapeutic avenue by a substitution in sRAGE in this pathology.

The objective of this study is to study the ability of the alveolar sRAGE level measured on broncho-alveolar lavage for assessment, to discriminate the clinical degrees of control of severe asthma in children.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
1 Day 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • severe asthma
  • Weight greater than or equal to 5 kg

排除标准

  • Current respiratory infection
  • Bronchopulmonary dysplasia or prematurity < 34 weeks
  • Diffuse infiltrative pneumonia
  • Cystic fibrosis, primary ciliary dyskinesia
  • Known immune deficiencies;
  • Congenital heart disease;
  • Cardiomyopathy;
  • Ongoing pericarditis, myopericarditis, endocarditis;
  • Chronic valvular pathology;
  • Known autoimmune disease;
  • Neuromuscular pathology;

结局指标

主要结局

alveolar sRAGE level

时间窗: at inclusion

ability of the alveolar sRAGE level measured on bronchoalveolar lavage (BAL) for assessment to discriminate the clinical degrees of control of severe asthma in children

次要结局

  • plasma sRAGE level(at inclusion)

研究者

发起方
University Hospital, Clermont-Ferrand
申办方类型
Other
责任方
Sponsor

研究点 (1)

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Alveolar and Serum sRAGE in Severe Asthma in Children | 临床试验