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NCT Number: NCT06776042

Upper Airway Inflammation and Olfaction: Mechanisms of Loss and Recovery

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.

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Key information

Conditions

Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location status: Recruiting

Location contact

Pr. Valérie Hox

CONTACT

[email protected]

+3227648675

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Nasal brushing of the olfactory cleft

Other

Nasal brushing of the olfactory cleft

Smell testing

Other

Smell testing using the Sniffin' Sticks Test

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Study contacts

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

Valérie Hox, MD, PhD

CONTACT

[email protected]

+3227648675

Sponsors and collaborators

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Other

Registry information

Acronym: IMMUNODOR

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jan 15, 2025
Registry last updated
Apr 27, 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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