Investigating the effects of Dupilumab on nasal barrier function in chronic rhinosinusitis patients
Effect of Dupilumab on Nasal Epithelial Barrier Function in Patients With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) - an Exploratory Pilot Study
Medical University of Vienna · NCT06398873
This study is testing if the medication Dupilumab can improve the nasal barrier function in people with chronic rhinosinusitis, especially those with nasal polyps.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Medical University of Vienna (other) |
| Drugs / interventions | dupilumab |
| Locations | 1 site (Vienna, Austria) |
| Trial ID | NCT06398873 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-99 who suffer from chronic rhinosinusitis, either with or without nasal polyps, and are planned to receive Dupilumab treatment.
Not a fit: Patients with severe anatomic variations in the nasal cavity, cystic fibrosis, or those who are permanently immunosuppressed may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for patients with chronic rhinosinusitis, enhancing their nasal barrier function and overall quality of life.
How similar studies have performed: While this approach is novel in its specific focus on nasal barrier function in chronic rhinosinusitis, similar studies have shown promise in understanding treatment effects on epithelial barriers.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Vienna, Austria
- Medical University of Vienna — Vienna, Austria, Austria (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Chronic Rhinosinusitis With Nasal Polyps, Chronic Rhinosinusitis Without Nasal Polyps