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NCT Number: NCT06398873

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

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.

Recruiting

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Vienna

Vienna, Austria, A-1090

Location status: Recruiting

Location contact

Aldine Tu, MA

SUB_INVESTIGATOR

Christoph Krall, PhD

SUB_INVESTIGATOR

Fana Kidane, PhD

SUB_INVESTIGATOR

Julia Eckl-Dorna, MD, PhD

CONTACT

[email protected]

004314040034380

Julia Eckl-Dorna, MD, PhD

SUB_INVESTIGATOR

Mohammed Zghaebi, MA

SUB_INVESTIGATOR

Nicholas Campion, MD

SUB_INVESTIGATOR

Sven Schneider, MD

PRINCIPAL_INVESTIGATOR

Tina Bartosik, MD

SUB_INVESTIGATOR

Victoria Stanek, MA

CONTACT

[email protected]

Victoria Stanek, MA

SUB_INVESTIGATOR

About this study

Primary objective 1: Characterization of differences in barrier function of the nasal epithelium in patients suffering from CRSsNP, CRSwNP with and without asthma or N-ERD (in absence of therapy with monoclonal antibodies). T Primary objective 2: Effect of dupilumab treatment on barrier function of the nasal epithelium in patients suffering from CRSwNP with and without asthma or N-ERD.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • A mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
  • Patients with clinically meaningful comorbidity as determined by the evaluating committee
  • Patients with a history of exacerbation of chronic rhinosinusitis 4 weeks prior to the screening visit
  • Intake of a burst of systemic corticosteroids for the treatment of CRS 4 weeks prior to the screening visit

Treatment and study plan

Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT]

Drug

300mg/2 weeks

Primary outcomes

  1. Barrier function in CRSsNP and CRSwNP

    Time frame: 1 Visit (baseline)

    Cell index (xCELLigence)

  2. Barrier function in CRSwNP with Dupilumab

    Time frame: 3 Visits (baseline, 3 months, 6 months)

    Cell index (xCELLigence)

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

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

Acronym: EpiBar

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
May 3, 2024
Registry last updated
May 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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