Effect of Dupilumab on Nasal Epithelial Barrier Function in Patients With CRSwNP
- Sponsor
- Medical University of Vienna
- Study ID
- NCT06398873
- Status
- Recruiting
Conditions
- Chronic Rhinosinusitis With Nasal Polyps
- Chronic Rhinosinusitis Without Nasal Polyps
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 99 Years
- Healthy Volunteers
- Not accepted
Interventions
- Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT] — DRUG300mg/2 weeks
Study Details
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.
Key Dates
- Start date
- Jun 6, 2024
- Status verified
- Jun 2024
- Primary completion
- Sep 1, 2026
- Completion
- Sep 1, 2027
Study Design
- Enrollment
- 80 participants (estimated)
Arms
- Arm: CRSsNP
- Arm: CRSwNPDupilumab
Primary Outcome Measure
Barrier function in CRSsNP and CRSwNP [ Time Frame: 1 Visit (baseline) ]
Related Studies
- Dupilumab Treatment Effects in an Ethnically Diverse Population With Chronic Rhinosinusitis With Nasal PolyposisRecruiting · Montefiore Medical Center · The Bronx, New York
- The Role of IL5 in Epithelial Cell IntegrityEARLY_PHASE1 · Recruiting · Johns Hopkins University · Baltimore, Maryland
- 3D Printing to Improve Nasal Irrigation OutcomeRecruiting · Ohio State University · Columbus, Ohio
- Efficacy and Safety of 186 mcg of OPN-375 Nasal Spray Twice a Day (BID) in Adolescents With Chronic Rhinosinusitis Without Nasal PolypsPHASE3 · Recruiting · Optinose US Inc. · Gilbert, Arizona