Ireland
--:--IST
Starting soon Not applicable

Interpretation of the Role of Eosinophils in Diffuse Interstitial Pneumopathies

NCT06980844 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2025-05-31
Last updated
2025-05-20

Condition(s) studied

Interstitial Lung Disease

Investigational drug(s) / intervention(s)

No intervention: no treatment

No intervention: no treatment: translationnal study: Only blood sampling and imaging will be performed on two groups of ILD patients.

Study summary

Diffuse interstitial lung diseases (ILDs) represent a group of rare, heterogeneous disorders of various etiologies, all sharing a common histopathological feature: fibrotic remodeling of the pulmonary parenchyma induced by a chronic inflammatory process. Although the prevalence of ILDs in France has recently been estimated at 19.4 per 100,000 inhabitants per year, they are frequently encountered in clinical practice due to their need for specialized hospital care. ILDs are associated with significant morbidity and a poor prognosis, despite the heavy burden of current therapeutic strategies. This highlights the urgent need to identify new therapeutic targets for these diseases.

Eosinophilic polymorphonuclear cell could represent one such target. As a source of pro-fibrotic mediators such as TGF-β, they may contribute to pulmonary fibrosis from a clinical standpoint. Our hypothesis is that a component of bronchial exacerbation in ILD patients may involve a type 2 immune response through the recruitment and activation of eosinophilic polymorphonuclear cell.

Given their role in pro-fibrotic signaling, our objective is to characterize type 2 immunity parameters-focusing in particular on eosinophilic polymorphonuclear cell-using a multi-source approach in a cohort of ILD patients. If type 2 immunity is significantly present in this population (referred to as ILD-eosinophilic polymorphonuclear cell), the investigators will investigate the role of eosinophilic polymorphonuclear cell in vitro using a co-culture model involving eosinophilic polymorphonuclear cell and respiratory epithelial cells (both bronchial and alveolar). Based on the results obtained, future prospects include evaluating the effects of biotherapy within this model as a preliminary step toward a subsequent clinical study.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * PID-PNE interest group (n= 30 patients): Adult subjects followed for chronic interstitial lung disease with a follow-up duration \> 1 year with at least one biological sample showing a circulating PNE level \> 300/mm3 during their follow-up, without any prescription of systemic corticosteroid therapy and antifibrotic agents (PIRFENIDONE and NINTENADIB) responsible for modulation of the eosinophil count. 15 patients followed for Idiopathic Pulmonary Fibrosis (IPF) and 15 patients with another etiology of ILD will be selected. * PNE ILD control group (n= 30 patients): Adult subjects with ILD with a PNE level \< 150/mm3 during their follow-up, without any prescription of systemic corticosteroid therapy and antifibrotic agents (PIRFENIDONE and NINTENADIB). - Have signed a consent form. * Be affiliated with a health insurance plan. Exclusion Criteria: * Patients under 18 years of age * Patients over 75 years of age * Pregnant patients * Subjects with eosinophilic granulomatosis with polyangiitis (Churg-Strauss) * Subjects with hypereosinophilic syndrome (NEP \> 1500/mm3) * Subjects with chronic idiopathic eosinophilic pneumonia (Carrington disease) * Subjects with drug-induced interstitial lung disease * Subjects with respiratory failure (acute and chronic: SaO2 \> 92% throughout the procedure) * Subjects with unstable heart disease * Subjects with severe comorbidities * Subjects receiving oxygen therapy * Subjects deprived of liberty or under guardianship -Patients subject to a guardianship and judicial safeguard measure * PID-PNE or non-PID PNE patients receiving systemic corticosteroid therapy or antifibrotic treatment (PIRFENIDONE and NINTENADIB)

Primary outcome measure(s)

  • The highlighting of significant differences in parameters related to T2 immunity (notably eosinophilic polymorphonuclear cell) in diffuse interstitial lung disease-EPN cells patients compared to no eosinophilic polymorphonuclear cell in ILDs patients. — Two years
    T2 immunity caractirization. A description of the variables will be provided, by median and interquartile for quantitative variables, taking into account the numbers in each group, and by number and percentages for qualitative variables. Differences in variables between the two groups will be tested using the Chi-square test or Fisher's exact test for qualitative variables and the Mann-Whitney test for quantitative variables. To address the primary objective, variables with a p-value \<0.20 will be included in the multivariate model. A forward-backward multiple logistic regression will be performed to identify predictive factors for differentiation in epithelial damage and fibrotic phenomena between the two population groups.

Trial sites (1)

FacilityCityRegionStatus
Drci Foch Hospital Suresnes Suresnes
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06980844 on ClinicalTrials.gov ↗ ← All trials in France