Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)PheRhEosNCT07524127
Phenotyping of Type 2 Inflammation Profile by Rheology of Nasal Secretions and Tissue Quantification of Eosinophilic Polymorphonuclear Cells in the Middle Turbinate
A study testing Sinonasal sample collection and inflammatory assessment in people with Chronic Rhinosinusitis With Nasal Polyps (CRSwNP), run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
- What is being tested?
- Sinonasal sample collection and inflammatory assessment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 1 Aug 2026to 1 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
University hospital Montpellier
Montpellier
Valentin FAVIER, MD, 04 67 33 67 33 ext. 33, v-favier@chu-montpellier.fr
Jérémy CHARRIOT, MD, 04 67 33 59 37 ext. 33, j-charriot@chu-montpellier.fr
About this study
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.
Read the 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.
- Being tested
- Sinonasal sample collection and inflammatory assessment
- Keywords
- Rheology, Nasal Polyposis, mucus, T2 inflammation
- Medical subject headings
- Nasal Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sinonasal sample collection and inflammatory assessmentProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Characterize and compare patients with and without CRSwNP | Experimental | Experimental: Characterize and compare patients with and without CRSwNP Assessment of rheological and inflammatory variables Receives: Procedure: Sinonasal sample collection and inflammatory assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1
Secondary outcomes (13)
Comparison of elasticity (G' [Pa]) of sinonasal secretions
Measuring mucus elasticity (G, in Pa) with the Rheomuco device. Comparison of viscosity between CRSwNP and a control group of patients without CRSwNP
Measured: Day 1
Comparison of critical stress of sinonasal secretions
Measuring mucus critical stress (SigmaC) with the Rheomuco device. Comparison of viscosity between CRSwNP patients and a control group of patients without CRSwNP
Measured: Day 1
Comparison of tissue eosinophilia
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.
Measured: Day 1
Comparison of circulating eosinophilia
Measurement of blood eosinophil levels (absolute count in cells/mm3 and percentage). Comparison between CRSwNP patients and the control group.
Measured: Day 1
Comparison of Fractional exhaled Nitric Oxide (FeNO)
Measurement of FeNO levels (in ppb) as a marker of airway inflammation. Comparison between the two study groups.
Measured: Day 1
Comparison of clinical characteristics and quality of life using Sino-Nasal Outcome Test-22 questionnaire
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).
Measured: Day 1
Comparison of clinical characteristics and quality of life using Dysfonctionnement Nasal Chronique questionnaire
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).
Measured: Day 1
Comparison of clinical characteristics and quality of life using Chronic Rhinosinusitis questionnaire
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.
Measured: Day 1
Comparison of endoscopic severity (Nasal Polyp Score)
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.
Measured: Day 1
Association between local and systemic inflammation
Correlation analysis between tissue eosinophil counts (local) and circulating biomarkers (blood eosinophils, FeNO).
Measured: Day 1
Association between rheological variables and inflammation
Correlation analysis between mucus rheological parameters (G', G'', sigma c) and local/systemic inflammatory markers.
Measured: Day 1
Comparison of Lund-Mackay score
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.
Measured: Day 1
CT mucus score
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
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 May 2028 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)Studies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valentin FAVIER, MD, Principal investigator, University Hospital, MontpellierJérémy CHARRIOT, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07524127
- Sponsor's protocol ID
- RECHMPL24_0379
- Other IDs
- 2025-A01490-49
- Acronym
- PheRhEos
- Status last verified
- Apr 2026
- First submitted
- 26 Mar 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phenotyping of Type 2 Inflammation Profile by Rheology of Nasal Secretions and Tissue Quantification of Eosinophilic Polymorphonuclear Cells in the Middle Turbinate
- ClinicalTrials.gov ID
- NCT07524127
- Acronym / sponsor ID
- PheRhEos / RECHMPL24_0379
- Keywords
- Rheology, Nasal Polyposis, mucus, T2 inflammation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Characterize and compare patients with and without CRSwNP | Experimental | Procedure: Sinonasal sample collection and inflammatory assessmentExperimental: Characterize and compare patients with and without CRSwNP Assessment of rheological and inflammatory variables |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient requiring sinonasal surgery
- For patients in the CRSwNP group:
- Clinical examination revealing, for at least 12 weeks prior to inclusion, 2 or more of the following symptoms:
- Nasal congestion
- Rhinorrhea (anterior/posterior)
Key exclusion criteria (8 listed)
- Inability to provide a sinonasal secretion sample by blowing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sinonasal sample collection and inflammatory assessmentCollection 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 | Procedure or surgery | Characterize and compare patients with and without CRSwNP |
Primary outcome
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
13 secondary outcomes
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
CT mucus score
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
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Clinical Trial of TQC2731 Injection in Patients With Chronic Sinusitis and Nasal Polyps
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Active, not recruitingPhase 2
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RecruitingObservational study
Prospective, Non-interventional Single-arm Study With Tezepelumab to Investigate the Change in Clinical and Patient-reported Outcomes in Patients With CRSwNP in Real-world (PETRICHOR)
Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Valentin FAVIER, MD principal investigator
University Hospital, Montpellier
Jérémy CHARRIOT study director
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sinonasal sample collection and inflammatory assessment in people with Chronic Rhinosinusitis With Nasal Polyps (CRSwNP), run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Valentin Favier, MD (04 67 33 67 33 ext. 33, v-favier@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of viscosity of sinonasal secretions (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.