Upper Airway Inflammation and Olfaction: Mechanisms of Loss and Recovery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-22

Study Completion Date

2026-09-30

Brief Summary

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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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Detailed Description

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Conditions

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Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Chronic rhinosinusitis patients

Patients suffering from chronic rhinosinusitis will undergo smell testing as well as nasal brushing of the olfactory cleft

Group Type EXPERIMENTAL

Nasal brushing of the olfactory cleft

Intervention Type OTHER

Nasal brushing of the olfactory cleft

Smell testing

Intervention Type OTHER

Smell testing using the Sniffin' Sticks Test

Interventions

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Nasal brushing of the olfactory cleft

Intervention Type OTHER

Smell testing

Smell testing using the Sniffin' Sticks Test

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes