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NCT Number: NCT07524127

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

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.

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Key information

Conditions

Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) Nasal Polyps Nose Diseases Otorhinolaryngologic Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps Respiratory Tract Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Comparison of viscosity of sinonasal secretions

    Time frame: Day 1

    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

Secondary outcomes

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

    Time frame: Day 1

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

  2. Comparison of critical stress of sinonasal secretions

    Time frame: Day 1

    Measuring mucus critical stress (SigmaC) with the Rheomuco device. Comparison of viscosity between CRSwNP patients and a control group of patients without CRSwNP

  3. Comparison of tissue eosinophilia

    Time frame: Day 1

    Quantification of the number of eosinophils per mm3 in the middle turbinate tissue via histological analysis (HE staining). Comparison between CRSwNP patients and the control group.

  4. Comparison of circulating eosinophilia

    Time frame: Day 1

    Measurement of blood eosinophil levels (absolute count in cells/mm3 and percentage). Comparison between CRSwNP patients and the control group.

  5. Comparison of Fractional exhaled Nitric Oxide (FeNO)

    Time frame: Day 1

    Measurement of FeNO levels (in ppb) as a marker of airway inflammation. Comparison between the two study groups.

  6. Comparison of clinical characteristics and quality of life using Sino-Nasal Outcome Test-22 questionnaire

    Time frame: Day 1

    Assessment of disease severity and quality of life using standardized questionnaire SNOT-22 (Sino-Nasal Outcome Test-22).

    The SNOT-22 is scored on a scale from 0 (no problem) to 5 (the most severe problem possible), with a total score ranging from 0 to 110 (higher scores indicate worse outcomes).

  7. Comparison of clinical characteristics and quality of life using Dysfonctionnement Nasal Chronique questionnaire

    Time frame: Day 1

    Assessment of disease severity and quality of life using standardized questionnaire DyNaChron (Dysfonctionnement Nasal Chronique); It comprises 55 items divided into six symptom categories: nasal obstruction, anterior rhinorrhoea, posterior rhinorrhoea, smell disorders, facial pain/headaches, and chronic cough. The score ranges from 0 (no impact) to 550 (maximum impact).

  8. Comparison of clinical characteristics and quality of life using Chronic Rhinosinusitis questionnaire

    Time frame: Day 1

    Assessment of disease severity and quality of life using standardized questionnaire CRSpro (Chronic Rhinosinusitis).

    The CRSpro questionnaire comprises 12 items divided into three categorizes: physical symptoms, sensory impairment and psychosocial effects. Each item is rated on a scale of 0 (not at all) to 4 (very much), and the total score ranges from 0 to 48.

  9. Comparison of endoscopic severity (Nasal Polyp Score)

    Time frame: Day 1

    Evaluation of polyposis severity through endoscopic examination using the Nasal Polyp Score (scale 0 to 4).

    Nasal Polyp Score= 0: no polyps; 1: one polyp extending beyond the middle meatus; 2: two polyps extending beyond the middle meatus; 3: one polyp reaching the inferior turbinate; 4: one polyp extending beyond the inferior turbinate.

  10. Association between local and systemic inflammation

    Time frame: Day 1

    Correlation analysis between tissue eosinophil counts (local) and circulating biomarkers (blood eosinophils, FeNO).

  11. Association between rheological variables and inflammation

    Time frame: Day 1

    Correlation analysis between mucus rheological parameters (G', G'', sigma c) and local/systemic inflammatory markers.

  12. Comparison of Lund-Mackay score

    Time frame: Day 1

    Evaluation of sinus disease severity using the Lund-Mackay score obtained from sinonasal computed tomography scans and comparison between CRSwNP patients and control patients.

    The Lund-Mackay scoring system based on sinonasal computed tomography (CT). Each paranasal sinus (maxillary, frontal, sphenoid, anterior ethmoid, posterior ethmoid) is scored as 0 = no abnormality, 1 = partial opacification, or 2 = complete opacification. The ostiomeatal complex is scored 0 = not obstructed or 2 = obstructed, with no intermediate value. The total score ranges from 0 to 24, with higher scores indicating more severe chronic rhinosinusitis.

  13. CT mucus score

    Time frame: Day 1

    Evaluation of thoracic computed tomography findings using the CT mucus score and comparison between CRSwNP patients and control patients.

    The CT mucus score quantifies the burden of mucus plugs by counting the number of bronchopulmonary segments occluded by mucus on multidetector CT (MDCT). This system generates a quantitative score representing the extent of mucus impaction, with higher scores reflecting greater mucus plugging and more severe airway obstruction

Study contacts

Contact information is provided by the study sponsor or research team.

Jérémy CHARRIOT

CONTACT

[email protected]

04 67 33 59 37 ext. 33

Valentin Favier, MD

CONTACT

[email protected]

04 67 33 67 33 ext. 33

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Acronym: PheRhEos

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 13, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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