Eosinophils Endotypes in Chronic Airway Inflammatory Diseases

Launched by UNIVERSITY HOSPITAL, LILLE · Dec 3, 2019

Keywords

ClinConnect Summary

This clinical trial is studying the role of eosinophils, a type of white blood cell involved in inflammation, in patients with conditions like eosinophilic asthma, chronic sinusitis, and eosinophilic rhinitis. The goal is to better understand how eosinophils contribute to these airway diseases and to identify which patients might benefit most from new treatments that target these cells, rather than relying solely on long-term steroid medications.

To participate in the trial, patients need to be social insurance holders and willing to follow the study procedures. Eligible participants include those with uncontrolled moderate to severe asthma or those with chronic sinusitis and nasal polyps who have not responded well to standard treatments. Healthy individuals without any airway issues will also be included as a comparison group. Participants will undergo tests to analyze their eosinophils, and the information gathered may help improve treatment options for people suffering from these challenging conditions.

Gender

ALL

Eligibility criteria

• 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
• Exclusion Criteria:
• 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...)