Severe Eosinophilic Asthma Phenotypes During Childhood Have Various Origins
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Severe Asthma, Asthma in Children. Basic parameters: from 6 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Trajectories of Severe Eosinophilic Asthma During Childhood: Experience of the SAMP (Severe Asthma Molecular Phenotype) Cohort
Overview
Study of the clinical evolution at 10 years of children from the SAMP cohort (severe asthma, eosinophilic or not, allergic or not) in order to understand the different possible evolutions of these phenotypes at different ages.
Detailed description
Multiple sensitizations but also blood eosinophilia are associated with the persistence of exacerbations during childhood. The pivotal role of eosinophilia in the pathophysiology of allergic asthma and more generally of severe asthma in the pediatric population has made it an important research topic for many years. The indirect demonstration of bronchial inflammation by analyzing blood eosinophilia is common practice, especially when monitoring the effectiveness of biotherapies. However, blood eosinophilia is not always clearly related to bronchial eosinophilia.
On the other hand, several teams have recently sought to highlight the recurrence of allergen sensitization profiles associated with severe asthma, in order to identify predictive factors of clinical evolution.
Finally, recent studies have shown that the nasal microbiota plays an important role in the onset, development and severity of asthma.
Our study will allow us to study the clinical evolution at 10 years of the children from the SAMP cohort (severe asthma, eosinophilic or not, allergic or not) in order to understand the different possible evolutions of these phenotypes at different ages. These phenotypic trajectories have an important therapeutic implication, leading to the prescription of personalized treatments, in particular biologics (monoclonal antibodies).
Primary objective To evaluate, in children with moderate to severe asthma, the control of asthma according to the therapeutic load, atopic pathologies during childhood and initial serum levels of blood eosinophils and biomarkers of eosinophil activation Secondary objective Evaluate the evolution of asthma phenotypes according to the associated atopic pathologies (allergic rhinitis, atopic dermatitis and food allergy), according to the number of atopic comorbidities and their severity.
Study of the microbiota in children followed for moderate to severe asthma.
Practical procedure The investigator record the new tests prescribed as part of the routine care of these patients (respiratory function tests, blood tests) and ask them to complete a questionnaire (no travel required specifically for the study). In the event of a blood test prescribed and carried out in the department, the investigator will take an additional 2 ml, and perform a nasal and skin swab.
Primary outcome measures
- asthma control 1 [Time frame: through study completion, 4 years]
- asthma control 2 [Time frame: through study completion, 4 years]
Secondary outcome measures (6)
- asthma severity 1 [Time frame: through study completion, 4 years]
- asthma severity 2 [Time frame: through study completion, 4 years]
- atopic comorbidities 1 [Time frame: through study completion, 4 years]
- atopic comorbidities 2 [Time frame: through study completion, 4 years]
- atopic comorbidities 3 [Time frame: through study completion, 4 years]
- nasal and skin microbiota [Time frame: 1 day at inclusion of patient]
Eligibility criteria
Inclusion criteria
- absence of opposition from the legal representative of the patient and if possible from the patient himself.
- patient with moderate to severe asthma at preschool or school age, previously included in SAMP Cohort
Exclusion criteria
- Patient included in another clinical study.
- Lack of coverage by social security.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Allergy Department, Trousseau Hospital — Paris
Identifiers
NCT: NCT05762627 · APHP220980