RecruitingNCT06683261

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

Real-life Evaluation of the Efficacy of Biologicals in CRSwNP


Sponsor

Universitaire Ziekenhuizen KU Leuven

Enrollment

300 participants

Start Date

Sep 23, 2022

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria4

  • Participant must be at least 18 years of age at the time of signing the informed consent.
  • Capable of giving signed informed consent.
  • Participants should have CRSwNP.
  • Participants should fulfil the reimbursement criteria for their prescribed biological (omalizumab, mepolizumab and/or dupilumab).

Exclusion Criteria1

  • \. 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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Interventions

BIOLOGICALOmalizumab

biological prescribed as add-on treatment as part of the standard of care

BIOLOGICALDupilumab

biological prescribed as add-on treatment as part of the standard of care

BIOLOGICALMepolizumab 100 mg

biological prescribed as add-on treatment as part of the standard of care


Locations(8)

Onze Lieve Vrouw hospital Aalst

Aalst, Belgium

General hospital Sint-Jan Bruges

Bruges, Belgium

University hospital Saint-Luc

Brussels, Belgium

University hospital of Antwerp

Edegem, Belgium

Hospital Zuid-Oost Limburg

Genk, Belgium

University Hospital Brussels

Jette, Belgium

University hospitals Leuven

Leuven, Belgium

CHU de Liège

Liège, Belgium

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NCT06683261


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