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

Launched by MEDICAL UNIVERSITY OF VIENNA · Apr 30, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how a medication called dupilumab affects the barrier function of the nasal lining in patients with chronic rhinosinusitis (CRS), which can occur with or without nasal polyps. The researchers want to understand how this condition impacts the nasal lining and how dupilumab treatment might help improve it. Participants will be involved in tests that examine the function of their nasal cells and the overall health of their nasal passages.

To join the study, participants must be between 18 and 99 years old and have been diagnosed with chronic rhinosinusitis. There are two groups: one with nasal polyps and one without. Some people may not be eligible, such as those who are pregnant, have certain medical conditions, or have had recent severe flare-ups of their condition. Those who take part can expect to provide samples for research and receive treatment with dupilumab, which aims to help improve their nasal symptoms. This study could help doctors better understand how to treat chronic rhinosinusitis in the future.

Gender

ALL

Eligibility 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