Interpretation of the Role of Eosinophils in Diffuse Interstitial Pneumopathies

NCT06980844 | Not Yet Recruiting

• 1 other identifier: 2022_0155
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Interstitial Lung Disease

Keywords

T2 response; Eosinophil; Pulmonary fibrosis

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  Two years

Secondary Outcomes (3)

• To define whether blood eosinophilia is analogous to bronchial eosinophilia in ILDs patients

  Two years

• To determine whether bronchial eosinophilia is a characteristic that can be targeted by anti-T2 biotherapy

  two years

• validate these observations from an experimental point of view on an in vitro model of healthy epithelium in coculture with PNE from the blood of PID patients presenting with eosinophilia.

  two years

Study Arms (2)

ILDs eosinophilic polymorphonuclear cell

OTHER

Patients with diffuse interstitial lung disease with eosinophilic polymorphonuclear cell \> 300/mm3 in blood (ILDs-eosinophilic polymorphonuclear cell group of interest)

Other: No intervention: no treatment

ILDs NO eosinophilic polymorphonuclear cell

OTHER

eosinophilic polymorphonuclear cell \< 100/mm3 in blood (ILDs non-eosinophilic polymorphonuclear cell control group)

Other: No intervention: no treatment

Interventions

No intervention: no treatment OTHER

translationnal study: Only blood sampling and imaging will be performed on two groups of ILD patients.

Also known as: No intervention

ILDs NO eosinophilic polymorphonuclear cell; ILDs eosinophilic polymorphonuclear cell

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: Pregnant patients will not be included in the study
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hopital Foch: lead

Study Sites (1)

Drci Foch Hospital

Suresnes, Suresnes, 92160, France

Location

MeSH Terms

Conditions

Lung Diseases, Interstitial; Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients with diffuse interstitial lung disease with eosinophilic polymorphonuclear cell \> 300/mm3 in blood (ILD-eosinophilic polymorphonuclear cell group of interest) and eosinophilic polymorphonuclear cell \< 100/mm3 in blood (ILD non-eosinophilic polymorphonuclear cell control group)

Study Record Dates

• First Submitted: April 9, 2025
• First Posted: May 20, 2025
• Study Start: May 31, 2025
• Primary Completion (Estimated): August 28, 2028
• Study Completion (Estimated): February 28, 2029
• Last Updated: May 20, 2025

Record last verified: 2025-05

Locations

FR (1)