Phenotyping of Type 2 Inflammation Profile by Rheology of Nasal Secretions and Tissue Quantification of Eosinophilic Polymorphonuclear Cells in the Middle Turbinate

Обзор

This monocentric, interventional study (category RIPH2) aims to characterize the rheological properties of sinonasal secretions in patients with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP). The primary objective is to determine differences in mucus viscosity between CRSwNP patients and a control group. By establishing a correlation between local rheology and systemic Type 2 inflammation biomarkers, the study seeks to develop a non-invasive, rapid "point-of-care" tool to refine patient phenotyping and improve the personalization of biological treatments.

Подробное описание

The study compares two groups of adult patients undergoing endonasal surgery at Montpellier University Hospital: 30 patients with CRSwNP and 30 control patients without inflammatory sinonasal pathology.

Research-Specific Interventions include:

* Rheology Analysis: Nasal secretions are collected by blowing onto an aluminum plate. Viscosity (G'), elasticity (G'), and critical stress (sigma c) are measured using the Rheomuco® device at 37°C. * Histology: Intraoperative biopsies of the middle turbinate are performed to quantify tissue eosinophils through serialized HE staining and immunolabeling (EPX, IL-5 receptor). * Blood Collection: An additional 7 mL EDTA tube is collected to create a serum bank for ancillary studies of Type 2 cytokines (IL-5, IL-13). * Clinical Correlation: Data are correlated with clinical scores (SNOT-22), sinonasal CT scans, and respiratory function tests (FeNO, spirometry) to evaluate the link between local tissue inflammation and systemic profiles.

Вмешательства

• Процедура Sinonasal sample collection and inflammatory assessment
  Collection of sinonasal secretions by blowing onto an aluminum plate Collection of blood sample: 7 ml for serum isolation to create a serum bank Biopsy of the middle turbinate head: under nasal endoscopy, a millimetric tissue sample will be taken from the middle turbinate mucosa using biopsy forceps

Первичные конечные точки

• Comparison of viscosity of sinonasal secretions [Срок оценки: Day 1]

Вторичные конечные точки (12)

• Comparison of elasticity (G' [Pa]) of sinonasal secretions [Срок оценки: Day 1]
• Comparison of critical stress of sinonasal secretions [Срок оценки: Day 1]
• Comparison of tissue eosinophilia [Срок оценки: Day 1]
• Comparison of circulating eosinophilia [Срок оценки: Day 1]
• Comparison of Fractional exhaled Nitric Oxide (FeNO) [Срок оценки: Day 1]
• Comparison of clinical characteristics and quality of life using Sino-Nasal Outcome Test-22 questionnaire [Срок оценки: Day 1]
• Comparison of clinical characteristics and quality of life using Dysfonctionnement Nasal Chronique questionnaire [Срок оценки: Day 1]
• Comparison of clinical characteristics and quality of life using Chronic Rhinosinusitis questionnaire [Срок оценки: Day 1]
• Comparison of endoscopic severity (Nasal Polyp Score) [Срок оценки: Day 1]
• Association between local and systemic inflammation [Срок оценки: Day 1]
• Association between rheological variables and inflammation [Срок оценки: Day 1]
• Comparison of Lund-Mackay score [Срок оценки: Day 1]

Критерии участия

Критерии включения

• Patient requiring sinonasal surgery
• For patients in the CRSwNP group:

Presence of nasal polyposis defined according to EPOS 2020 recommendations:

Clinical examination revealing, for at least 12 weeks prior to inclusion, 2 or more of the following symptoms:

• Nasal congestion
• Rhinorrhea (anterior/posterior)
• Or a Facial pain/pressure
• Or a Reduced or lost sense of smell AND visible polyps in both nasal cavities on endoscopic examination of the middle meatus (regardless of size).

Критерии исключения

• Inability to provide a sinonasal secretion sample by blowing

• Conditions causing secondary nasal polyposis (e.g., cystic fibrosis, ciliary dyskinesia, immune disorders, allergic fungal sinusitis)
• Illiteracy
• Lack of consent
• Legal protection status (guardianship, curatorship, etc.)
• No social security coverage
• Persons deprived of liberty by judicial or administrative decision
• Participation in another study with an ongoing exclusion period

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Франция · 1 центр

• University hospital Montpellier — Montpellier

Идентификаторы

NCT: NCT07524127 · RECHMPL24_0379 · 2025-A01490-49

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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