RECRUITING Phase 4 ClinicalTrials.gov

Mepolizumab and in Office-office Nasal Polypectomy in Patients With Chronic Rhinosinusitis (CRS).

Sponsor: Instituto de Investigación Marqués de Valdecilla • ClinicalTrials.gov ID: NCT07814924

Registry updated: 2026-09-11

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Description

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. 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.

Interventions

surgical arm (Procedure)
polypectomy in the office and will not receive mepolizumab treatment.
Mepolizumab 100 MG (Drug)
will not undergo in-office nasal polypectomy and will start treatment with mepolizumab directly after randomization.
combined arm (Other)
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.

Eligibility criteria

Inclusion Criteria: 1. Participant 18 years of age or older 2. 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. 3. 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 4. 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 5. Patients have been informed and signed consent to participate in the study. Exclusion Criteria: 1. Any serious or uncontrolled systemic or psychiatric illness that prevents a correct cognitive or endoscopic assessment or does not advise participation in the study. 2. Unilateral localized secondary CRS (odontogenic, fungal ball, tumor). 3. 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. 4. Pregnancy/ breast feeding. 5. Hypersensitivity to mepolizumab or its excipients. 6. Patients unable to complete the questionnaire or follow prescribed treatment. 7. Patients who are participating in another clinical trial related to polyposis or asthma. 8. Previously documented failure with IL-5/IL-5 receptor biologics

Conditions

Chronic Rhinosinusitis With Nasal Polyps

Locations

Hospital de Cruces — Barakaldo, Spain
Hospital de Jerez — Jerez de la Frontera, Spain
Hospital Puerta del Hierro — Madrid, Spain
Hospital de Salamanca — Salamanca, Spain
Hospital universitario Marques de Valdecilla — Santander, Spain
Hospital Universitario Virgen Macarena — Seville, Spain
Hospital de Valladolid — Valladolid, Spain

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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