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Alveolar and Serum sRAGE in Severe Asthma in Children

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05364996
Acronym
sRAGE
Enrollment
85
Registered
2022-05-06
Start date
2022-06-01
Completion date
2024-06-01
Last updated
2024-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma in Children

Keywords

soluble receptor for advanced glycation end products, inflammation

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.

Interventions

DIAGNOSTIC_TESTbronchial 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

DIAGNOSTIC_TESTBlood sampling

collection of 5 milliliters of blood for total white cells count, C-Reactive Protein, specific immunoglobulin E assays, serum sRAGE assay

Sponsors

University Hospital, Clermont-Ferrand
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Days to 16 Years
Healthy volunteers
No

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;

Design outcomes

Primary

MeasureTime frameDescription
alveolar sRAGE levelat inclusionability 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

MeasureTime frameDescription
plasma sRAGE levelat inclusionability of the plasmatic sRAGE level measured on blood for assessment to discriminate the clinical degrees of control of severe asthma in children

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026