Informations générales (source: ClinicalTrials.gov)
Peripheral Eosinophils Phenotypes in Airway Inflammatory Diseases: Towards Proper Clustering and Therapeutic Targeting (PLEIAD)
Observational
University Hospital, Lille (Voir sur ClinicalTrials)
mars 2020
mars 2024
29 juin 2024
Asthma and chronic rhinosinusitis with nasal polyps (CRSwNP) are frequently described as
unified airway inflammatory diseases. Both heavily impacts quality of life with
substantial productivity loss. They share the same pathophysiologic pattern based upon
proTh2 immune response with blood eosinophils recruitment. Eosinophils are the major
actor of persistent mucosal inflammation by promoting their own survival, by attracting
other inflammatory cells and by producing cytotoxic proteins involved in mucosal
remodeling.
Promising anti-Th2 therapeutic approaches (i.e.anti-IgE, anti-interleukin 5 (IL-5),
anti-IL-4, anti-IL-13) are considered as effective alternative options to long-term
corticosteroid treatment. Their advantage in recalcitrant CRSwNP is under consideration.
Moreover, we still need to delineate the good responders to improve theirs indications.
The objective is to assess blood eosinophil immunophenotypes in asthma or CRSwNP. Flow
cytometric expression of activation markers on eosinophil membrane will be compared with
a group of healthy subjects. Innovative data on eosinophil involvement in airway diseases
will be obtained. The major outcome will be to depict patients' endotypes for a better
selection of immunotherapies.
Etablissements
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHU Lille - 59000 - Lille - France | Cécile Chenivesse, MD, Ph | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
For all groups:
- Social insured patient
- Patient willing to comply with all procedures of the study and its duration
- Provision of signed and dated informed consent form prior to any study specific
procedure
For Group 1:
- Patients with moderate to severe uncontrolled asthma, confirmed by relevant clinical
symptoms and proven variable airway obstruction, and assessed by an expert
pulmonologist according to spirometry criteria (absolute and weighed Forced
Expiratory Volume (FEV) and Forced Vital Capacity (FVC) before and after 2
test),(see CRF for details). Uncontrolled asthma will be defined by an ACQ score ≥
1.5. or acute exacerbation
For Groups 2 and 3:
- Patients with medically refractory bilateral sino-nasal polyposis requiring sinus
surgery, according to an expert rhinologist. CRSwNP diagnosis is based on the
presence of bilateral nasal polyps from both side of middle turbinates on
nasoendoscopy and bilateral sinus opacification on CT scan. Briefly, CRSwNP is
considered as refractory when symptoms are still not controlled after 3 courses of
oral corticosteroid and double dose of nasal corticosteroid during the last 12
months
- Patients with both uncontrolled asthma and recalcitrant CRSwNP with or without
concomitant aspirin-exacerbated respiratory disease (AERD) (group 3)
For Group 4:
- Healthy subjects without any airway disease or any atopic status, as assessed by a
questionnaire and a medical examination
For all groups:
- Social insured patient
- Patient willing to comply with all procedures of the study and its duration
- Provision of signed and dated informed consent form prior to any study specific
procedure
For Group 1:
- Patients with moderate to severe uncontrolled asthma, confirmed by relevant clinical
symptoms and proven variable airway obstruction, and assessed by an expert
pulmonologist according to spirometry criteria (absolute and weighed Forced
Expiratory Volume (FEV) and Forced Vital Capacity (FVC) before and after 2
test),(see CRF for details). Uncontrolled asthma will be defined by an ACQ score ≥
1.5. or acute exacerbation
For Groups 2 and 3:
- Patients with medically refractory bilateral sino-nasal polyposis requiring sinus
surgery, according to an expert rhinologist. CRSwNP diagnosis is based on the
presence of bilateral nasal polyps from both side of middle turbinates on
nasoendoscopy and bilateral sinus opacification on CT scan. Briefly, CRSwNP is
considered as refractory when symptoms are still not controlled after 3 courses of
oral corticosteroid and double dose of nasal corticosteroid during the last 12
months
- Patients with both uncontrolled asthma and recalcitrant CRSwNP with or without
concomitant aspirin-exacerbated respiratory disease (AERD) (group 3)
For Group 4:
- Healthy subjects without any airway disease or any atopic status, as assessed by a
questionnaire and a medical examination
For all groups:
- Patients with any other form of secondary CRSwNP (eg, cystic fibrosis, primary
ciliary dyskinesia).
- Patients with any form of secondary severe asthma (eg (non)eosinophilic
granulomatosis with polyangiitis, allergic bronchopulmonary aspergillosis)
- Patients taking or having taken systemic corticosteroid, leukotriene receptor
antagonist, theophylline or long-term macrolide therapy within 1 month prior to
sample collections, anti-immunoglobulin E therapy (omalizumab) anti-IL-5/5R or anti
IL-4R/anti-IL13 therapies within 6 months before inclusion
- Patients followed up for another inflammatory or auto-immune disease
- Previous allogeneic bone marrow transplant
- Patients with ongoing sub-cutaneous or sub-lingual anti-allergenic immunotherapies
- Patients with active smoking or history of smoking > 10 packages-year for asthma
patients
- Pregnant, breastfeeding, or lactating women
- Non-coverage by the social security insurance
- Patient unable to receive informed information
- Refusal to sign the consent form
- Unwillingness or inability to follow the study procedures, in the opinion of the
investigator
- Person deprived of the liberty
- Person benefiting from a system of legal protection (guardianship...)