NCT06683261 Real-life Evaluation of the Efficacy of Biologicals in Chronic Rhinosinusitis With Nasal Polyposis (CRSwNP)
| NCT ID | NCT06683261 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universitaire Ziekenhuizen KU Leuven |
| Condition | Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2022-09-23 |
| Primary Completion | 2026-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2022-09-23 with a primary completion date of 2026-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Contact & Investigator
Peter Hellings, MD,PhD
PRINCIPAL INVESTIGATOR
Universitaire Ziekenhuizen KU Leuven
Frequently Asked Questions
Who can join the NCT06683261 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Rhinosinusitis With Nasal Polyps (CRSwNP). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06683261 currently recruiting?
Yes, NCT06683261 is actively recruiting participants. Contact the research team at elien.borgers@uzleuven.be for enrollment information.
Where is the NCT06683261 trial being conducted?
This trial is being conducted at Aalst, Belgium, Bruges, Belgium, Brussels, Belgium, Edegem, Belgium and 4 additional locations.
Who is sponsoring the NCT06683261 clinical trial?
NCT06683261 is sponsored by Universitaire Ziekenhuizen KU Leuven. The principal investigator is Peter Hellings, MD,PhD at Universitaire Ziekenhuizen KU Leuven. The trial plans to enroll 300 participants.