Phenotyping of Type 2 Inflammation Profile by Rheology of Nasal Secretions and Tissue Quantification of Eosinophilic Polymorphonuclear Cells in the Middle Turbinate
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sinonasal sample collection and inflammatory assessment.
- Who it may be relevant to
- Registry conditions: Chronic Rhinosinusitis With Nasal Polyps (CRSwNP). Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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.
Interventions
- Procedure 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
Primary outcome measures
- Comparison of viscosity of sinonasal secretions [Time frame: Day 1]
Secondary outcome measures (12)
- Comparison of elasticity (G' [Pa]) of sinonasal secretions [Time frame: Day 1]
- Comparison of critical stress of sinonasal secretions [Time frame: Day 1]
- Comparison of tissue eosinophilia [Time frame: Day 1]
- Comparison of circulating eosinophilia [Time frame: Day 1]
- Comparison of Fractional exhaled Nitric Oxide (FeNO) [Time frame: Day 1]
- Comparison of clinical characteristics and quality of life using Sino-Nasal Outcome Test-22 questionnaire [Time frame: Day 1]
- Comparison of clinical characteristics and quality of life using Dysfonctionnement Nasal Chronique questionnaire [Time frame: Day 1]
- Comparison of clinical characteristics and quality of life using Chronic Rhinosinusitis questionnaire [Time frame: Day 1]
- Comparison of endoscopic severity (Nasal Polyp Score) [Time frame: Day 1]
- Association between local and systemic inflammation [Time frame: Day 1]
- Association between rheological variables and inflammation [Time frame: Day 1]
- Comparison of Lund-Mackay score [Time frame: Day 1]
Eligibility criteria
Inclusion criteria
- 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).
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 1 center
- University hospital Montpellier — Montpellier
Identifiers
NCT: NCT07524127 · RECHMPL24_0379 · 2025-A01490-49