Real Life Study of Biologicals in Patients With Severe CRSwNP

Recruiting now

Conditions studied: Chronic Rhinosinusitis With Nasal Polyps

In brief

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.

Key facts

Study ID

NCT05938972

Run by

University Hospital, Ghent

People needed

180

Starts

2022-03-01

Expected to finish

2030-12-31

Last updated by the study team

2024-04-15

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Patients who do not meet the reimbursement criteria of a biological therapy cannot participate in the study.

Where it is running

• Ghent University Hospital — Ghent, Belgium (enrolling)

Full record on ClinicalTrials.gov

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