Alveolar and Serum sRAGE in Severe Asthma in Children

Asthma in Children Clinical Trial

— sRAGE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05364996
• Other study ID #: RNI 2021 EGRON
• Secondary ID: 2022-A00218-35
• Status: Recruiting
• Start date: June 1, 2022
• Est. completion date: June 1, 2024

Study information

• Verified date: January 2024
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 85
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 16 Years

Eligibility

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;

Related Conditions & MeSH terms

• Asthma
• Asthma in Children

Intervention

Diagnostic Test:
• bronchial endoscopy with bronchoalveolar lavage (LBA)
Bronchial endoscopy under laryngeal mask and general anesthesia. BAL of saline at room temperature of 3 milliliters per kilogram limited to 20 milliliters x 3 according to recommendations
• Blood sampling
collection of 5 milliliters of blood for total white cells count, C-Reactive Protein, specific immunoglobulin E assays, serum sRAGE assay

Locations

Country	Name	City	State
France	CHU de Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	alveolar sRAGE level	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	at inclusion
Secondary	plasma sRAGE level	ability of the plasmatic sRAGE level measured on blood for assessment to discriminate the clinical degrees of control of severe asthma in children	at inclusion