Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)IMMUNODORNCT06776042
Upper Airway Inflammation and Olfaction: Mechanisms of Loss and Recovery
A study testing Nasal brushing of the olfactory cleft and Smell testing in people with Chronic Rhinosinusitis With Nasal Polyps (CRSwNP), run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
The goal of this clinical trial is to understand the mechanisms leading to olfactory dysfunction (OD) in chronic rhinosinusitis (CRS). The main questions it aims to answer are: Is the type 2 inflammation impacting the olfactory epithelium regeneration, leading to OD? Does a treatment interfering with one of the major… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
- What is being tested?
- Nasal brushing of the olfactory cleft and Smell testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteBelgium
- Study dates
- 22 May 2023to 30 Sep 2026
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least two of the following symptoms: nasal obstruction, rhinorrhoea, smell loss, facial pain for 12 weeks.
- Endoscopic visualisation of bilateral sinonasal polyps
- SSI (TDI) < 30.75 and decreased sense of smell subjectively
- Eosinophilia > 300/μl of blood Ku/l
- On a stable nasal steroid treatment for at least 4 weeks
Who cannot join
- Active smoking
- Primary and secondary immune deficiencies
- Ciliary diseases (cystic fibrosis, primary ciliary diskinesia)
- History of or current nasal malignancies
- < 18 years and > 70 years
- Patients unable to express consent
- Use of systemic corticosteroids for < 4 weeks before visit 1 • Use of systemic or local antibiotics for < 4 weeks before visit 1
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Cliniques Universitaires Saint-Luc
Brussels, 1200
Pr. Valérie Hox, +3227648675, valerie.hox@saintluc.uclouvain.be
About this study
The goal of this clinical trial is to understand the mechanisms leading to olfactory dysfunction (OD) in chronic rhinosinusitis (CRS). The main questions it aims to answer are:
- Is the type 2 inflammation impacting the olfactory epithelium regeneration, leading to OD?
- Does a treatment interfering with one of the major T2 inflammatory cytokines, have an impact on the mechanisms of OD in CRS?
Participants will undergo olfactory testing and nasal brushing before and after 3 months of treatment.
- Being tested
- Nasal brushing of the olfactory cleft, Smell testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal brushing of the olfactory cleftOther
Nasal brushing of the olfactory cleft
Smell testingOther
Smell testing using the Sniffin' Sticks Test
| Study group | Role | What they receive |
|---|---|---|
| Chronic rhinosinusitis patients | Experimental | Patients suffering from chronic rhinosinusitis will undergo smell testing as well as nasal brushing of the olfactory cleft Receives: Other: Nasal brushing of the olfactory cleft; Other: Smell testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genetic profile comparison after single-cell RNA sequencing
The primary objective of this study is to compare the genetic profile of the olfactory epithelium from T2 CRSwNP patients harvested with a nasal brush, to the olfactory epithelium from healthy controls (HC) by means of RNA sequencing.
Measured: Through study completion, an average of 2 years
Secondary outcomes (1)
Functional characterization of olfactory epithelium
The secondary objectives are to characterize the OE of T2 CRSwNP patients in a functional way by means of immunocytochemistry (ICC), calcium imaging, and proliferation assays, and to compare the results with healthy controls, patients with non-inflammatory OD and non-T2 CRSsNP.
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start22 May 2023
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (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 Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valérie Hox, MD, PhD, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06776042
- Sponsor's protocol ID
- 2022/15DEC/484
- Acronym
- IMMUNODOR
- Status last verified
- Apr 2026
- First submitted
- 6 Dec 2024
- Last updated
- 27 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Upper Airway Inflammation and Olfaction: Mechanisms of Loss and Recovery
- ClinicalTrials.gov ID
- NCT06776042
- Acronym / sponsor ID
- IMMUNODOR / 2022/15DEC/484
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 22 May 2023 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 15 Jan 2025 (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.
The goal of this clinical trial is to understand the mechanisms leading to olfactory dysfunction (OD) in chronic rhinosinusitis (CRS). The main questions it aims to answer are:
- Is the type 2 inflammation impacting the olfactory epithelium regeneration, leading to OD?
- Does a treatment interfering with one of the major T2 inflammatory cytokines, have an impact on the mechanisms of OD in CRS?
Participants will undergo olfactory testing and nasal brushing before and after 3 months of treatment.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic rhinosinusitis patients | Experimental | Other: Nasal brushing of the olfactory cleft, Other: Smell testingPatients suffering from chronic rhinosinusitis will undergo smell testing as well as nasal brushing of the olfactory cleft |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- At least two of the following symptoms: nasal obstruction, rhinorrhoea, smell loss, facial pain for 12 weeks.
- Endoscopic visualisation of bilateral sinonasal polyps
- SSI (TDI) < 30.75 and decreased sense of smell subjectively
- Eosinophilia > 300/μl of blood Ku/l
- On a stable nasal steroid treatment for at least 4 weeks
Key exclusion criteria (7 listed)
- Active smoking
- Primary and secondary immune deficiencies
- Ciliary diseases (cystic fibrosis, primary ciliary diskinesia)
- History of or current nasal malignancies
- < 18 years and > 70 years
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 |
|---|---|---|
| Nasal brushing of the olfactory cleftNasal brushing of the olfactory cleft | Other | Chronic rhinosinusitis patients |
| Smell testingSmell testing using the Sniffin' Sticks Test | Other | Chronic rhinosinusitis patients |
Primary outcome
Genetic profile comparison after single-cell RNA sequencing
Time frame: Through study completion, an average of 2 years
The primary objective of this study is to compare the genetic profile of the olfactory epithelium from T2 CRSwNP patients harvested with a nasal brush, to the olfactory epithelium from healthy controls (HC) by means of RNA sequencing.
1 secondary outcome
Functional characterization of olfactory epithelium
Time frame: Through study completion, an average of 2 years
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 27 Apr 2026.
Related trials for Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
RecruitingPhase 3
A Study to Assess the Efficacy and Safety of GSK5784283 (Felcorekibart) in Participants With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Nasal Polyps
RecruitingPhase 3
A Study of Lebrikizumab (LY3650150) in Participants With Chronic Rhinosinusitis and Nasal Polyps Treated With Intranasal Corticosteroids (CONTRAST-NP)
Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Active, not recruitingPhase 3
Clinical Trial of TQC2731 Injection in Patients With Chronic Sinusitis and Nasal Polyps
Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Active, not recruitingPhase 2
Long-term Safety and Efficacy Evaluation of Lunsekimig in Adult Participants With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) Who Completed a Previous Lunsekimig CRSwNP Clinical Study
Chronic Rhinosinusitis With Nasal Polyps
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.
Valérie Hox, MD, PhD principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasal brushing of the olfactory cleft and Smell testing in people with Chronic Rhinosinusitis With Nasal Polyps (CRSwNP), run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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 5 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 27 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 Belgium. 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 Valérie Hox, MD, PhD (+3227648675, valerie.hox@saintluc.uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genetic profile comparison after single-cell RNA sequencing (time frame: Through study completion, an average of 2 years). 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 27 Apr 2026.