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Recruiting NCT06683261

Real-life Evaluation of the Efficacy of Biologicals in Chronic Rhinosinusitis With Nasal Polyposis (CRSwNP)

Trial Parameters

Condition Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Sponsor Universitaire Ziekenhuizen KU Leuven
Study Type OBSERVATIONAL
Phase N/A
Enrollment 300
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2022-09-23
Completion 2026-01
Interventions
OmalizumabDupilumabMepolizumab 100 mg

Brief Summary

The goal of this observational study is to learn more about the real-world efficacy of biologics in patients with chronic rhinosinusitis with nasal polyposis (CRSwNP). All patients who are 18 years or older, who have CRSwNP and are eligible for reimbursement of a biological for the indication of CRSwNP can be included. The main question is the efficacy of biologics in real life after 24 weeks. The main focus are patient reported outcomes measured via several questionnaires and the nasal polyp score, scored with nasal endoscopy.

Eligibility Criteria

Inclusion Criteria: 1. Participant must be at least 18 years of age at the time of signing the informed consent. 2. Capable of giving signed informed consent. 3. Participants should have CRSwNP. 4. Participants should fulfil the reimbursement criteria for their prescribed biological (omalizumab, mepolizumab and/or dupilumab). Exclusion Criteria: 1\. Patients treated with other biological therapies in the 3 months prior to the current biological (this is not applicable to patients who are in the trial and switch biological).

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