Upper Airway Inflammation and Olfaction: Mechanisms of Loss and Recovery (IMMUNODOR)

April 24, 2026 updated by: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Chronic rhinosinusitis patients
Patients suffering from chronic rhinosinusitis will undergo smell testing as well as nasal brushing of the olfactory cleft
Other: Nasal brushing of the olfactory cleft
Nasal brushing of the olfactory cleft
Other: Smell testing
Smell testing using the Sniffin' Sticks Test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, an average of 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional characterization of olfactory epithelium
Time Frame: Through study completion, an average of 2 years
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.
Through study completion, an average of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Investigators

  • Principal Investigator: Valérie Hox, MD, PhD, Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 22, 2023

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

December 6, 2024

First Submitted That Met QC Criteria

January 9, 2025

First Posted (Actual)

January 15, 2025

Study Record Updates

Last Update Posted (Actual)

April 27, 2026

Last Update Submitted That Met QC Criteria

April 24, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022/15DEC/484

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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