Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Conditions
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.
Interventions
OTHERNasal brushing of the olfactory cleft
Nasal brushing of the olfactory cleft
OTHERSmell testing
Smell testing using the Sniffin' Sticks Test
Sponsors
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Belgium
Contacts
CONTACTValérie Hox, MD, PhD
PRINCIPAL_INVESTIGATORValérie Hox, MD, PhD
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Outcome results
None listed