Alveolar and Serum sRAGE in Severe Asthma in Children

NCT05364996 | Unknown

• 2 other identifiers: RNI 2021 EGRON2022-A00218-35
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma in Children

Keywords

soluble receptor for advanced glycation end products; inflammation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• plasma sRAGE level

  at inclusion

Study Arms (1)

child with severe asthma

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.

Diagnostic Test: bronchial endoscopy with bronchoalveolar lavage (LBA); Diagnostic Test: Blood sampling

Interventions

bronchial endoscopy with bronchoalveolar lavage (LBA) DIAGNOSTIC_TEST

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

child with severe asthma

Blood sampling DIAGNOSTIC_TEST

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

child with severe asthma

Eligibility Criteria

• Age: 1 Day - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Child from 0 to 16 years old, eligible for bronchial endoscopy with bronchoalveolar lavage (BAL) 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.

You may qualify if:

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

You may not qualify if:

• 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;

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

bronchoalveolar lavage (LBA) and plasma

MeSH Terms

Conditions

Inflammation

Interventions

Bronchoscopy; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Pulmonary Surgical Procedures; Thoracic Surgical Procedures; Specimen Handling; Clinical Laboratory Techniques; Punctures; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2022
• First Posted: May 6, 2022
• Study Start: June 1, 2022
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: April 8, 2024

Record last verified: 2024-01

Locations

FR (1)