Mepolizumab, office nasal polyp removal, or both for chronic rhinosinusitis with nasal polyps
Compares mepolizumab, in-office polyp removal, and both together in people with recurrent nasal polyps.
Key facts
- Who runs it
- Instituto de Investigación Marqués de Valdecilla
- Where
- Spain7 sites in 1 countryChoose a country to see its sites
- Trial code
- Registry title
- Mepolizumab and in Office-office Nasal Polypectomy in Patients With Chronic Rhinosinusitis (CRS).
- Status
- Recruiting
- Phase
- Phase 4
- People taking part
- 75 people, planned
- Started
- 31 Dec 2024
- Expected to end
- 31 Dec 2026
- Type of study
- Interventional, 3 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- surgical arm
- Mepolizumab 100 MG
- combined arm
- Record updated
- 11 September 2026
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 swelling of the sinuses with growths in the nose) who need surgery and a biologic medicine. People will get mepolizumab, polyp removal in the clinic office, or both.
- Age
- 18 Years to 80 Years (the summary says 18 to 70 years)
- Sex
- All sexes can join.
- Disease stage
- Chronic rhinosinusitis with nasal polyps by the EPOS2020 guideline, with symptoms for ≥12 weeks. Polyps on both sides that came back after earlier sinus surgery (ESS). At least 3 of: type 2 inflammation, need for steroid tablets or injections (≥ 2 courses per yr or >3 months), SNOT ≥ 40, loss of smell ≥7 VAS, asthma.
- Earlier treatment
- Must have had sinus surgery (ESS) before. People whose treatment with IL-5/IL-5 receptor biologics clearly failed before cannot join.
- Biomarker or test result
- Blood eosinophil count (a type of white blood cell) ≥300 cells/µL, from a test no older than one year. Type 2 inflammation: tissue eos> 10/hpf, blood eos>250, or total IgE> 100.
Main reasons for not taking part
- Serious or uncontrolled body or mental illness that would affect the assessments
- Sinus disease caused by something else, such as teeth, fungus, tumor, cystic fibrosis, Churg-Strauss, Wegener, ciliary dyskinesia or immune deficiencies
- Pregnancy or breastfeeding
- Allergy to mepolizumab or its ingredients
- Taking part in another trial on polyps or asthma
The registry criteria, word for word
Show all 13 criteriaShow less
Who can take part
- Participant 18 years of age or older
- Patients with a diagnosis of CRS with polyposis according to the criteria of the EPOS2020 guideline:; Chronic rhinosinusitis with nasal polyps in adults is defined as presence of two or more symptoms, one of which should be either nasal blockage / obstruction / congestion or nasal discharge (anterior / posterior nasal drip); ± facial pain/pressure; ± reduction or loss of smell; for ≥12 weeks; and either endoscopic signs of nasal polyps, and/or CT changes: mucosal changes within the ostiomeatal complex and/or sinuses
- Patients with indication for biologic treatment according to the criteria of the EPOS2020 guideline. Presence of bilateral polyps in a patient who had ESS and three of the following criteria are required:; 3.1. Evidence of type 2 inflammation (tissue eos> 10/hpf* or blood eos>250, OR total IgE> 100); Whenever possible histology from previous surgery should be reviewed to confirm if eosinophilic pathology. If the previous surgery was performed more than 2 years earlier, a blood eosinophil count is essential, as the previous biopsy data may not be relevant; 3.2. Need for systemic corticosteroids or contraindication to systemic steroids (≥ 2 courses per yr, OR long term (>3 months); 3.3. Significantly impaired quality of life (SNOT ≥ 40); 3.4. Significant loss of smell (≥7 VAS); 3.5. Diagnosis of comorbid asthma
- Basal eosinophil count (BEC) ≥300 cells/µL for surgical naïve patients- or for those who have had surgery and have recurrence . The result of a previous analysis would be valid if it was obtained in a period of time not exceeding one year
- Patients have been informed and signed consent to participate in the study
Who cannot take part
- Previously documented failure with IL-5/IL-5 receptor biologics
- Any serious or uncontrolled systemic or psychiatric illness that prevents a correct cognitive or endoscopic assessment or does not advise participation in the study
- Hypersensitivity to mepolizumab or its excipients
- Unilateral localized secondary CRS (odontogenic, fungal ball, tumor)
- Bilateral diffuse secondary CRS (cystic fibrosis; eosinophilic granulomatosis with polyangiitis-S. de Churg-Strauss-; granulomatosis with polyangiitis-S de Wegener-; primary ciliary dyskinesia; selective immunodeficiencies
- Pregnancy/ breast feeding
- Patients unable to complete the questionnaire or follow prescribed treatment
- Patients who are participating in another clinical trial related to polyposis or asthma
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
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
This randomized, controlled multicenter trial will recruit patients aged 18 to 70 years with recurrent nasal polyposis requiring surgery and indication for biologic treatment according to EPOS 2020 guideline. Patients in the Mepolizumab arms will receive 100 mg of subcutaneous mepolizumab every 4 weeks for a total of 12 doses in addition to daily topical corticosteroid treatment.
Read full original descriptionShow less
All study procedures will be performed in five study visits and may take approximately 30 minutes. Clinical assessments include ifferent questionnaires and nasal endoscopy. This trial includes three treatment arms.
1. Combined group (In-office nasal polypectomy group with mepolizumab): This group will undergone in-office nasal polypectomy and will receive Mepolizumab. 2. Medical group (mepolizumab): This group will receive Mepolizumab. 3. Surgical group (In-office nasal polypectomy): This group will undergone in-office nasal polypectomy. The main advantage is that it allows comparison of mepolizumab versus surgery and surgery/mepolizumab versus surgery + mepolizumab, providing more information on the most effective therapeutic approach.
The presence of adverse effects will be assessed in each treatment arm.
The 3 groups in the trial
- surgical armExisting treatment, for comparison
This group of patients will undergo nasal polypectomy in the office and will not receive mepolizumab treatment.
- medical armTreatment being tested
This group of patients will not undergo in-office nasal polypectomy and will start treatment with mepolizumab directly after randomization.
Treatment: Mepolizumab 100 MG
- combined armTreatment being tested
This group of patients will undergo in-office nasal polypectomy before starting treatment with mepolizumab. Mepolizumab treatment will be administered at the surgical procedure visit or within 48 hours after the polypectomy.
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
- Mepolizumab and in Office-office Nasal Polypectomy in Patients With Chronic Rhinosinusitis (CRS). A Three Arm Study.
- Plain-language title
- Mepolizumab, office nasal polyp removal, or both 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.
- Fit questions
- Built from NCT07814924, who can take part
- Record updated
- 11 September 2026