Allergy Department, Trousseau Hospital
Paris, 75012, France
NCT Number: NCT05762627
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.
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Get Notified6 year and older
All sexes
Observational
Paris, 75012, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: through study completion, 4 years
Asthma control according to GINA (Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention, 2020. www.ginasthma.org.)
Time frame: through study completion, 4 years
Score of the Asthma Control Test (for children > 11 years old) and of the Asthma Control Test reserved for asthmatic children from 4 to 11 years old (ACT™, © 2002, by QualityMetric Incorporated Asthma France / French Control Test™ is a trademark of QualityMetric Incorporated. www.asthmacontroltest.com)
Time frame: through study completion, 4 years
Asthma severity according to GINA (Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention, 2022. www.ginasthma.org.)
Time frame: through study completion, 4 years
Respiratory function tests (spirometry and plethysmography)
Time frame: through study completion, 4 years
Rhinitis control score: ARIA score (Allergic Rhinitis and its Impact on Asthma) endorsed by the WHO (Bousquet J, van Cauwenberge P, Khaltaev N, and the WHO panel members: Allergic Rhinitis and Its Impact on Asthma. ARIA. In collaboration with the World Health Organization. J Allergy Clin Immunol 2001; 108: S1-S315)
Time frame: through study completion, 4 years
Eczema control score: SCORAD score (Scoring atopic dermatitis) (Dermatology 1993; n°186 p23-p31. European Task Force of Atopic Dermatitis)
Time frame: through study completion, 4 years
Food allergy
Time frame: 1 day at inclusion of patient
nasal and skin swabs for research of colonization with staphylococcus aureus
Contact information is provided by the study sponsor or research team.
Jocelyne Just, MD, PhD
CONTACT
Mélisande Bourgoin-Heck, MD, MSc
CONTACT
Assistance Publique - Hôpitaux de Paris
Other
Trajectories of Severe Eosinophilic Asthma During Childhood: Experience of the SAMP (Severe Asthma Molecular Phenotype) Cohort
Acronym: SAMP 2
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