Alveolar and Serum sRAGE in Severe Asthma in Children

Recruiting

• Conditions: Asthma in Children
• Interventions: Diagnostic Test: bronchial endoscopy with bronchoalveolar lavage (LBA); Diagnostic Test: Blood sampling

• Registration Number: NCT05364996
• Lead Sponsor: University Hospital, Clermont-Ferrand

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-03
• Study First Submitted QC: 2022-05-03
• Study First Posted: 2022-05-06
• Study Start: 2022-06-01
• Status Verified: 2024-01
• Last Update Submitted: 2024-04-05
• Last Update Posted: 2024-04-08
• Primary Completion: 2024-06-01
• Study Completion: 2024-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 85

Inclusion Criteria

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

Exclusion Criteria

• 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;

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
child with severe asthma	Blood sampling	Child eligible for bronchial endoscopy with bronchoalveolar lavage (LBA) for assessment of severe asthma. The diagnosis of asthma being established by a pneumo-pediatrician in the presence of a history of respiratory symptoms such as wheezing, shortness of breath, chest tightness and coughing variable in time and intensity, associated with a variable limitation expiratory flows.
child with severe asthma	bronchial endoscopy with bronchoalveolar lavage (LBA)	Child eligible for bronchial endoscopy with bronchoalveolar lavage (LBA) for assessment of severe asthma. The diagnosis of asthma being established by a pneumo-pediatrician in the presence of a history of respiratory symptoms such as wheezing, shortness of breath, chest tightness and coughing variable in time and intensity, associated with a variable limitation expiratory flows.

Primary Outcome Measures

Name	Time	Method
alveolar sRAGE level	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

Secondary Outcome Measures

Name	Time	Method
plasma sRAGE level	at inclusion	ability of the plasmatic sRAGE level measured on blood for assessment to discriminate the clinical degrees of control of severe asthma in children

Trial Locations

Locations (1)

CHU de Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France