Investigating the effects of Dupilumab on nasal barrier function in chronic rhinosinusitis patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to explore the barrier function of the nasal epithelium in patients with chronic rhinosinusitis with and without nasal polyps. It will involve a thorough functional and molecular characterization of the nasal epithelial barrier in these patients. The study will also assess the impact of Dupilumab treatment on the barrier function in patients suffering from chronic rhinosinusitis with nasal polyps. Various methodologies, including primary cell cultures, mass cytometry imaging, transcriptomic analysis, and cytokine and microbiome data, will be employed to achieve these objectives.

Why it matters

Who can join: the full rules

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

Where it's running

• Medical University of Vienna
  Vienna, Austria, Austria Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.