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Recruiting NCT06776042

Upper Airway Inflammation and Olfaction: Mechanisms of Loss and Recovery

No phase Interventional Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nasal brushing of the olfactory cleft, Smell testing.
Who it may be relevant to
Registry conditions: Chronic Rhinosinusitis With Nasal Polyps (CRSwNP). Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Other Nasal brushing of the olfactory cleft
    Nasal brushing of the olfactory cleft
  • Other Smell testing
    Smell testing using the Sniffin' Sticks Test

Primary outcome measures

  • Genetic profile comparison after single-cell RNA sequencing [Time frame: Through study completion, an average of 2 years]
Secondary outcome measures (1)
  • Functional characterization of olfactory epithelium [Time frame: Through study completion, an average of 2 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

Belgium · 1 center
  • Cliniques Universitaires Saint-Luc — Brussels

Identifiers

NCT: NCT06776042 · 2022/15DEC/484

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗