Effect of Dupilumab on Nasal Epithelial Barrier Function in Patients With CRSwNP
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorMedical University of Vienna
About this trial
The investigators aim to investigate two major so far unresolved topics in CRSwNP research: (1) Thorough functional and molecular characterisation of barrier function in patients suffering from CRSsNP and CRSwNP and (2) effect of dupilumab treatment on barrier function in polyp patients. This will be achieved in patient-derived samples by employing measurement of barrier function in primary cell cultures in combination with a mass cytometry based imaging approach, transcriptomic analysis as well as cytokine and microbiome data of individual patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18-99 years of age
Willingness to participate in the study
Suffer from chronic rhinosinusitis defined as in EPOS 2020 criteria, see main text
Group 1 (n=20, CRSsNP): Absence of nasal polyps
Disqualifiers
Pregnancy (as determined by ß-HCG test) or breast feeding
Patients with severe anatomic variations or deviations that do not allow access to all areas in the nasal cavity
Patients with cystic fibrosis or primary ciliary dyskinesia
Patients with permanent immunosuppression
Trial population
Patients with chronic rhinosinusitis with and without nasal polyps
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT]
Drug300mg/2 weeks
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: CRSsNP0 interventions
Group B: CRSwNP1 intervention
Trial outcomes
Primary outcomes
1
Barrier function in CRSsNP and CRSwNP
Cell index (xCELLigence)
Time frame
1 Visit (baseline)2
Barrier function in CRSwNP with Dupilumab
Cell index (xCELLigence)
Time frame
3 Visits (baseline, 3 months, 6 months)Sponsors and contacts
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Source ClinicalTrials.gov