Actively Recruiting

Age: 18Years - 99Years
All Genders
NCT06398873

Effect of Dupilumab on Nasal Epithelial Barrier Function in Patients With CRSwNP

Led by Medical University of Vienna · Updated on 2025-05-07

80

Participants Needed

1

Research Sites

168 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Effect of Dupilumab on Nasal Epithelial Barrier Function in Patients With CRSwNP

Who Can Participate

Age: 18Years - 99Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18-99 years of age
  • Willingness to participate in the study
  • Diagnosis of chronic rhinosinusitis according to EPOS 2020 criteria
  • Group 1 (CRSsNP): Absence of nasal polyps
  • Group 2 (CRSwNP): Presence of nasal polyps confirmed by endoscopy or CT and planned dupilumab therapy
  • Presence or absence of NSAID-Exacerbated Respiratory Disease (N-ERD)
  • Patients previously treated with monoclonal antibodies only if at least 6 months have passed since last treatment
Not Eligible

You will not qualify if you...

  • Pregnancy or breastfeeding
  • Severe anatomical nasal variations preventing access to all nasal areas
  • Diagnosis of cystic fibrosis or primary ciliary dyskinesia
  • Permanent immunosuppression
  • Mental conditions preventing understanding of the study
  • Clinically meaningful comorbidity as judged by the evaluation committee
  • History of chronic rhinosinusitis exacerbation within 4 weeks before screening
  • Use of systemic corticosteroid bursts for CRS treatment within 4 weeks before screening

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Medical University of Vienna

Vienna, Austria, Austria, A-1090

Actively Recruiting

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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