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Real Life Study of Biologicals in Patients With Severe CRSwNP

Recruitingn/aAges 18 Years - 80 YearsAllUniversity Hospital, Ghent
NCT05938972 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This study is a pragmatic, real-life, observational study recruiting adult patients with chronic rhinosinusitis with nasal polyposis who are eligible to start biologicals as standard treatment. The aim of this study is to observe the long-term outcomes of biologicals in CRSwNP patients with or without comorbid asthma in 'real life'. Moreover, the investigators will gain insight into the mechanisms of biologicals in the local and systemic immunity of these patients and investigate novel local and systemic biomarkers and predictors of response.

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📋 Eligibility rules (as published)
Inclusion Criteria: Patients must meet the following criteria to be eligible for the enrolment in the study: * Signed informed consent form (ICF), * Age between 18 and 80 years at time of signing ICF, * Able to comply with the study protocol, in the investigator's judgment, * In group one: patients with severe allergic and/or eosinophilic asthma, defined by being currently treated with a biological (SoC) OR starting treatment with a biological (SoC). * In group two: patients with CRSwNP with or without asthma, defined by starting treatment with a biological (SoC) and fulfill the criteria for reimbursement of a biological therapy Exclusion Criteria: Patients who do not meet the reimbursement criteria of a biological therapy cannot participate in the study.
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What it tests

  • Mepolizumab
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Where

1 site
Ghent University Hospital
Ghent, Belgium
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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