Effect of Dupilumab on Nasal Epithelial Barrier Function in Patients With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) - an Exploratory Pilot Study

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
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• 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

• Group 2 (N=60, CRSwNP): Presence of nasal polyps as confirmed by endoscopy or CT and planned therapy with dupilumab

• Presence or absence of non-steroidal anti-inflammatory drug (NSAID)-Exacerbated Respiratory Disease (N-ERD)

• Patients with a history of treatment with monoclonal antibodies will only be included if at least a washout period of 6 months has passed

Locations
Other Locations
Austria
Medical University of Vienna
RECRUITING
Vienna
Time Frame
Start Date: 2024-06-06
Estimated Completion Date: 2027-09-01
Participants
Target number of participants: 80
Treatments
CRSsNP
CRSwNP
Dupilumab
Sponsors
Leads: Medical University of Vienna

This content was sourced from clinicaltrials.gov