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

NCT07524127 | Not Yet Recruiting

• 2 other identifiers: RECHMPL24_03792025-A01490-49
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

Keywords

Rheology; Nasal Polyposis; mucus; T2 inflammation

Outcome Measures

Primary Outcomes (1)

• Comparison of viscosity of sinonasal secretions

  Measuring mucus viscosity (G", in Pa) with the Rheomuco device. Comparison of viscosity between CRSwNP (Chronic Rhinosinusitis with Nasal Polyposispatients) patients and a control group of patients without CRSwNP

  Day 1

Secondary Outcomes (13)

• Comparison of elasticity (G' [Pa]) of sinonasal secretions

  Day 1

• Comparison of critical stress of sinonasal secretions

  Day 1

• Comparison of tissue eosinophilia

  Day 1

• Comparison of circulating eosinophilia

  Day 1

• Comparison of Fractional exhaled Nitric Oxide (FeNO)

  Day 1

Study Arms (1)

Characterize and compare patients with and without CRSwNP

EXPERIMENTAL

Experimental: Characterize and compare patients with and without CRSwNP Assessment of rheological and inflammatory variables

Procedure: Sinonasal sample collection and inflammatory assessment

Interventions

Sinonasal sample collection and inflammatory assessment PROCEDURE

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

Characterize and compare patients with and without CRSwNP

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient requiring sinonasal surgery
• For patients in the CRSwNP group:
• Presence of nasal polyposis defined according to EPOS 2020 recommendations:
• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

University hospital Montpellier

Montpellier, France

Location

MeSH Terms

Conditions

Nasal Polyps

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Valentin FAVIER, MD

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

• Jérémy CHARRIOT

  University Hospital, Montpellier

  STUDY DIRECTOR

Central Study Contacts

Valentin Favier, MD

CONTACT

04 67 33 67 33; v-favier@chu-montpellier.fr

Jérémy CHARRIOT

CONTACT

04 67 33 59 37; j-charriot@chu-montpellier.fr

Study Design

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

Model Details: All study participants will get the same intervention but participants will be divided into two groups: with or without chronic rhinosinusitis with nasal polyps (CRSwNP).

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: April 13, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

FR (1)