Effect of Dupilumab on nasal epithelial barrier function in patients with Chronic Rhinosinusitis with nasal polyps (CRSwNP) – an exploratory pilot study

Phase 1

Recruiting

Conditions: Chronic rhinosinusitis with nasal polyps, Chronic rhinosinusitis without nasal polyps
MedDRA version: 23.1Level: PTClassification code: 10084742Term: Chronic rhinosinusitis without nasal polyps Class: 100000004855
MedDRA version: 20.1Level: PTClassification code: 10080060Term: Chronic rhinosinusitis with nasal polyps Class: 100000004855
Therapeutic area: Diseases [C] - Otorhinolaryngologic Diseases [C09]

Registration Number: CTIS2023-509815-10-00

Lead Sponsor: Medical University Of Vienna

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 80

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 for asthma or polyps 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