Evaluating the effectiveness of biologics for chronic rhinosinusitis with nasal polyps
Real-life Evaluation of the Efficacy of Biologicals in CRSwNP
Universitaire Ziekenhuizen KU Leuven · NCT06683261
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 |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven (other) |
| Drugs / interventions | omalizumab, mepolizumab, dupilumab |
| Locations | 8 sites (Aalst and 7 other locations) |
| Trial ID | NCT06683261 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients who have received other biological therapies within the last three months may not benefit from this study.
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 performed: Other studies have shown promising results with biologics in treating similar conditions, indicating a potential for success in this approach.
Eligibility criteria
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 this trial is running
Aalst and 7 other locations
- 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)
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Chronic Rhinosinusitis With Nasal Polyps, Chronic Rhinosinusitis, biologicals, CRSwNP, real-world data study, mepolizumab, omalizumab, dupilumab