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
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.
- 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
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- 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