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RECRUITING

NCT07814924

PHASE4

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

Sponsor: Instituto de Investigación Marqués de Valdecilla

View on ClinicalTrials.gov

Summary

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.

Official title: Mepolizumab and in Office-office Nasal Polypectomy in Patients With Chronic Rhinosinusitis (CRS). A Three Arm Study.

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-12-31

Completion Date

2026-12-31

Last Updated

2026-09-11

Healthy Volunteers

Conditions

Chronic Rhinosinusitis With Nasal Polyps

Interventions

PROCEDURE

surgical arm

polypectomy in the office and will not receive mepolizumab treatment.

DRUG

Mepolizumab 100 MG

will not undergo in-office nasal polypectomy and will start treatment with mepolizumab directly after randomization.

OTHER

combined arm

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.

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

Locations (7)

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