Upper Airway Inflammation and Olfaction: Mechanisms of Loss and Recovery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorCliniques universitaires Saint-Luc- Université Catholique de Louvain
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Active smoking
Primary and secondary immune deficiencies
Ciliary diseases (cystic fibrosis, primary ciliary diskinesia)
History of or current nasal malignancies
Trial design
Design model
Single group
Treatments tested in this trial
Nasal brushing of the olfactory cleft
Other interventionNasal brushing of the olfactory cleft
Smell testing
Other interventionSmell testing using the Sniffin' Sticks Test
Treatment groups
140 Participants
are divided into 1 treatment groupGroup A: Chronic rhinosinusitis patientsExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Genetic profile comparison after single-cell RNA sequencing
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.
Time frame
Through study completion, an average of 2 yearsSecondary outcomes
1
Functional characterization of olfactory epithelium
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.
Time frame
Through study completion, an average of 2 yearsSponsors and contacts
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Source ClinicalTrials.gov