Upper Airway Inflammation and Olfaction: Mechanisms of Loss and Recovery
Overview
- Phase
- Not Applicable
- Intervention
- Nasal brushing of the olfactory cleft
- Conditions
- Not specified
- Sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Enrollment
- 140
- Locations
- 2
- Primary Endpoint
- Genetic profile comparison after single-cell RNA sequencing
- Status
- Recruiting
- Last Updated
- 5 days ago
Overview
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.
Investigators
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
Arms & Interventions
Chronic rhinosinusitis patients
Patients suffering from chronic rhinosinusitis will undergo smell testing as well as nasal brushing of the olfactory cleft
Intervention: Nasal brushing of the olfactory cleft
Chronic rhinosinusitis patients
Patients suffering from chronic rhinosinusitis will undergo smell testing as well as nasal brushing of the olfactory cleft
Intervention: Smell testing
Outcomes
Primary Outcomes
Genetic profile comparison after single-cell RNA sequencing
Time Frame: 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 Outcomes
- Functional characterization of olfactory epithelium(Through study completion, an average of 2 years)