Upper Airway Inflammation and Olfaction: Mechanisms of Loss and Recovery

NCT06776042 | Recruiting

• 1 other identifier: 2022/15DEC/484
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

Outcome Measures

Primary Outcomes (1)

• 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.

  Through study completion, an average of 2 years

Secondary Outcomes (1)

• Functional characterization of olfactory epithelium

  Through study completion, an average of 2 years

Study Arms (1)

Chronic rhinosinusitis patients

EXPERIMENTAL

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; Other: Smell testing

Interventions

Nasal brushing of the olfactory cleft OTHER

Nasal brushing of the olfactory cleft

Chronic rhinosinusitis patients

Smell testing OTHER

Smell testing using the Sniffin' Sticks Test

Chronic rhinosinusitis patients

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (1)

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

RECRUITING

Study Officials

• Valérie Hox, MD, PhD

  Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Valérie Hox, MD, PhD

CONTACT

+3227648675; valerie.hox@saintluc.uclouvain.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2024
• First Posted: January 15, 2025
• Study Start: May 22, 2023
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-04

Locations

BE (1)