Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05762627 |
| Other study ID # |
APHP220980 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 2023 |
| Est. completion date |
March 2027 |
Study information
| Verified date |
February 2023 |
| Source |
Assistance Publique - Hôpitaux de Paris |
| Contact |
Mélisande Bourgoin-Heck, MD, MSc |
| Phone |
+33 (0)1-71-73-87-46 |
| Email |
Melisande.bourgoin-heck[@]aphp.fr |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
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.
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.
