Asthma in ChildrensRAGENCT05364996
Alveolar and Serum sRAGE in Severe Asthma in Children
An observational study of Asthma in Children, run by University Hospital, Clermont-Ferrand at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 1 day to 16 years
- Conditions the study is for
- Asthma in Children
- What is being tested?
- bronchial endoscopy with bronchoalveolar lavage (LBA) and Blood sampling
- How many people
- 85 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2022to 1 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 16 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- severe asthma
- Weight greater than or equal to 5 kg
Who cannot join
- Current respiratory infection
- Bronchopulmonary dysplasia or prematurity < 34 weeks
- Diffuse infiltrative pneumonia
- Cystic fibrosis, primary ciliary dyskinesia
- Known immune deficiencies;
- Congenital heart disease;
Show all 11Show fewer
- Cardiomyopathy;
- Ongoing pericarditis, myopericarditis, endocarditis;
- Chronic valvular pathology;
- Known autoimmune disease;
- Neuromuscular pathology;
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de Clermont-Ferrand
Clermont-Ferrand, 63000
Lise Laclautre, +33473754963, promo_interne_drci@chu-clermontferrand.fr
Carole Egron
About this study
Official title: Cross-sectional Pilot Study of the Alveolar and Serum sRAGE Biomarker in Severe Asthma in Children.
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
- Being tested
- bronchial endoscopy with bronchoalveolar lavage (LBA), Blood sampling
- Keywords
- soluble receptor for advanced glycation end products, inflammation
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Blood samplingDiagnostic test
collection of 5 milliliters of blood for total white cells count, C-Reactive Protein, specific immunoglobulin E assays, serum sRAGE assay
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: bronchial endoscopy with bronchoalveolar lavage (LBA); Diagnostic Test: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at inclusion
Secondary outcomes (1)
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
Measured: at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2022
- Study start1 Jun 2022
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05364996
- Sponsor's protocol ID
- RNI 2021 EGRON
- Other IDs
- 2022-A00218-35
- Acronym
- sRAGE
- Status last verified
- Jan 2024
- First submitted
- 3 May 2022
- Last updated
- 8 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-sectional Pilot Study of the Alveolar and Serum sRAGE Biomarker in Severe Asthma in Children.
- ClinicalTrials.gov ID
- NCT05364996
- Acronym / sponsor ID
- sRAGE / RNI 2021 EGRON
- Conditions
- Asthma in Children
- Keywords
- soluble receptor for advanced glycation end products, inflammation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 6 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| child with severe asthma | – | Diagnostic Test: bronchial endoscopy with bronchoalveolar lavage (LBA), Diagnostic Test: Blood samplingChild 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. |
Who may qualify
- Ages
- 1 day to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- severe asthma
- Weight greater than or equal to 5 kg
Key exclusion criteria (11 listed)
- Current respiratory infection
- Bronchopulmonary dysplasia or prematurity < 34 weeks
- Diffuse infiltrative pneumonia
- Cystic fibrosis, primary ciliary dyskinesia
- Known immune deficiencies;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Diagnostic test | child with severe asthma |
| Blood samplingcollection of 5 milliliters of blood for total white cells count, C-Reactive Protein, specific immunoglobulin E assays, serum sRAGE assay | Diagnostic test | child with severe asthma |
Primary outcome
alveolar sRAGE level
Time frame: 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
1 secondary outcome
plasma sRAGE level
Time frame: at inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
CHU de Clermont-Ferrand
Clermont-Ferrand, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma in Children, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
alveolar sRAGE level (time frame: at inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2024.