Investigating eosinophils in chronic airway inflammatory diseases

Peripheral Eosinophils Phenotypes in Airway Inflammatory Diseases: Towards Proper Clustering and Therapeutic Targeting

This study is trying to learn more about eosinophils in people with severe asthma or nasal polyps to see if it can help improve treatments for these conditions.

Quick facts

• Study type: Observational
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Hospital, Lille (other)
• Drugs / interventions: omalizumab
• Locations: 1 site (Lille)
• Trial ID: NCT04187976 on ClinicalTrials.gov

What this trial studies

This observational study focuses on understanding the role of eosinophils in chronic airway inflammatory diseases such as eosinophilic asthma and chronic rhinosinusitis with nasal polyps. It aims to assess blood eosinophil immunophenotypes and their activation markers to identify potential responders to anti-Th2 therapies. The study will involve patients with moderate to severe uncontrolled asthma or medically refractory bilateral sino-nasal polyposis, with a focus on improving treatment strategies for these conditions.

Who should consider this trial

Good fit: Ideal candidates include patients with moderate to severe uncontrolled asthma or those with medically refractory bilateral sino-nasal polyposis.

Not a fit: Patients with well-controlled asthma or those without eosinophilic involvement may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more targeted and effective treatments for patients suffering from eosinophilic asthma and chronic sinusitis.

How similar studies have performed: Other studies have shown promise in targeting eosinophilic pathways in asthma and chronic rhinosinusitis, suggesting a potential for success in this approach.

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...)

Where this trial is running

Lille

• CHU Lille — Lille, France (RECRUITING)

Study contacts

• Principal investigator: Cécile Chenivess, MD,PhD — University Hospital, Lille
• Study coordinator: Cécile Chenivesse, MD,PhD

Conditions: Eosinophilic Asthma, Chronic Sinusitis, Eosinophilic Rhinitis, Eosinophil, asthma, chronic rhinosinusitis with nasal polyps, biotherapy, endotype