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

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status

Enrolling

Conditions

Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

Treatments

Other: Smell testing

Other: Nasal brushing of the olfactory cleft

Study type

Interventional

Funder types

Other

Identifiers

NCT06776042

2022/15DEC/484

Details and patient eligibility

About

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.

Enrollment

140 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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