Upper Airway Inflammation and Olfaction: Mechanisms of Loss and Recovery

Not Applicable

Recruiting

• Conditions: Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

• Registration Number: NCT06776042
• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-22
• Study First Submitted: 2024-12-06
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-09
• Last Update Submitted: 2025-01-09
• Study First Posted: 2025-01-15
• Last Update Posted: 2025-01-15
• Primary Completion: 2025-12-01
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 140

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Genetic profile comparison after single-cell RNA sequencing	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 Outcome Measures

Name	Time	Method
Functional characterization of olfactory epithelium	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.

Trial Locations

Locations (1)

Cliniques Universitaires Saint-Luc; 🇧🇪 Bruxelles, Belgium