Evaluating the effectiveness of biologics for chronic rhinosinusitis with nasal polyps
Official title: Real-life Evaluation of the Efficacy of Biologicals in CRSwNP
Run by Universitaire Ziekenhuizen KU Leuven · NCT06683261 · Data updated 2026-11-12
This study is testing how well biologic treatments work for adults with chronic rhinosinusitis and nasal polyps to see if they are more effective than standard treatments.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Drugs / interventions | omalizumab, mepolizumab, dupilumab |
| Locations | 8 sites (Aalst and 7 other locations) |
| Status | Recruiting |
| Started | September 23, 2022 |
| Main results expected | January 2026 |
| Study ends | December 2026 |
| Registry record updated | November 12, 2024 |
| Trial ID | NCT06683261 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 and older with a diagnosis of chronic rhinosinusitis with nasal polyps who meet the criteria for reimbursement of biologic therapies.
✕Probably not a fit
Patients who have received other biological therapies within the last three months may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to assess the real-world efficacy of biologic treatments in patients diagnosed with chronic rhinosinusitis with nasal polyps (CRSwNP). Participants aged 18 and older who meet the reimbursement criteria for biologics will be included. The study will focus on patient-reported outcomes and nasal polyp scores measured through questionnaires and nasal endoscopy after 24 weeks of treatment. The goal is to better understand how these biologics perform in everyday clinical settings compared to standard treatments.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of biologics, potentially improving treatment options for patients with CRSwNP.
How similar studies have gone: Other studies have shown promising results with biologics in treating similar conditions, indicating a potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion 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).
Where it's running
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Onze Lieve Vrouw hospital Aalst
Aalst, Belgium Recruiting -
General hospital Sint-Jan Bruges
Bruges, Belgium Recruiting -
University hospital Saint-Luc
Brussels, Belgium Recruiting -
University hospital of Antwerp
Edegem, Belgium Recruiting -
Hospital Zuid-Oost Limburg
Genk, Belgium Recruiting -
University Hospital Brussels
Jette, Belgium Recruiting
Show 2 more locations
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University hospitals Leuven
Leuven, Belgium Recruiting -
CHU de Liège
Liège, Belgium Recruiting
Study contacts
- Principal investigator: Peter Hellings, MD,PhD — Universitaire Ziekenhuizen KU Leuven
- Study coordinator: Elien Borgers, MSc
- Email: elien.borgers@uzleuven.be
- Phone: 003216342037
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Metabolic and Immunologic Biomarkers in Chronic Rhinosinusitis with Nasal Polyps
This study tests whether metabolic and immune markers in nasal tissue and blood differ between people with nasal polyps and those without, to help understand CRSwNP and find potential diagnostic clues.
-
Triamcinolone-loaded nanocapsules after endoscopic nasal surgery
This trial tests whether a triamcinolone acetonide–loaded nanocapsule spray is better than saline irrigation for healing after endoscopic nasal surgery in adults with chronic rhinosinusitis and nasal polyps.
-
Smell training in CRS patients with smell loss
This study tests whether a 3-month smell training program can improve smell function and related immune and mental health measures in adults with chronic rhinosinusitis and smell loss.
-
Tezepelumab in real-world CRSwNP: a real-world look at patient outcomes
This study tests tezepelumab in adults with chronic rhinosinusitis with nasal polyps to see how their symptoms and daily life change in routine care over about two years.
-
PROPEL corticosteroid‑releasing sinus implants — IBUKI cohort
This project tests how safe and well PROPEL corticosteroid‑releasing sinus implants work for people in Japan with chronic rhinosinusitis who undergo endoscopic sinus surgery.
-
BBT002 in healthy adults and in people with chronic rhinosinusitis with nasal polyps
This study tests BBT002 versus placebo to see how it acts, how safe it is, and whether it helps people with chronic rhinosinusitis with nasal polyps, with or without asthma.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.