How well biologic medicines work in everyday care for chronic rhinosinusitis with nasal polyps
Observes omalizumab, dupilumab or mepolizumab in adults with nasal polyps and chronic sinus inflammation.
Key facts
- Who runs it
- Universitaire Ziekenhuizen KU Leuven
- Where
- Belgium8 sites in 1 countryChoose a country to see its sites
- Trial code
- Registry title
- Real-life Evaluation of the Efficacy of Biologicals in Chronic Rhinosinusitis With Nasal Polyposis (CRSwNP)
- Status
- Recruiting
- People taking part
- 300 people, planned
- Started
- 23 Sept 2022
- Expected to end
- Dec 2026
- Type of study
- Observational
- Treatments tested
- Omalizumab
- Dupilumab
- Mepolizumab 100 mg
- Record updated
- 12 November 2024
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with chronic rhinosinusitis with nasal polyps (long-lasting sinus swelling with growths in the nose). They must have been prescribed a biological medicine for it. The study watches how well these medicines work in daily life.
- Age
- 18 years or older.
- Sex
- All sexes can join.
- Disease stage
- Chronic rhinosinusitis with nasal polyps (CRSwNP).
- Earlier treatment
- People must meet the insurance payment rules for their prescribed biological (omalizumab, mepolizumab and/or dupilumab). People cannot join if they had another biological therapy in the 3 months before their current biological. This does not apply to people already in the trial who switch biological.
Main reasons for not taking part
- Treatment with another biological therapy in the 3 months before the current biological
- Not able to give signed consent
The registry criteria, word for word
Show all 5 criteriaShow less
Who can take part
- Participant must be at least 18 years of age at the time of signing the informed consent
- Capable of giving signed informed consent
- Participants should have CRSwNP
- Participants should fulfil the reimbursement criteria for their prescribed biological (omalizumab, mepolizumab and/or dupilumab)
Who cannot take part
- 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)
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
Treatments tested
- Omalizumab
- Dupilumab
- Mepolizumab 100 mg
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Real-life Evaluation of the Efficacy of Biologicals in CRSwNP
- Plain-language title
- How well biologic medicines work in everyday care for chronic rhinosinusitis with nasal polypsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 15 November 2026.
- Record updated
- 12 November 2024