RecruitingPhase 4NCT07814924

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

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


Sponsor

Instituto de Investigación Marqués de Valdecilla

Enrollment

75 participants

Start Date

Dec 31, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Mepolizumab 100 MG, combined arm, and others for people with chronic rhinosinusitis with nasal polyps. The study is currently recruiting participants at 7 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREsurgical arm

polypectomy in the office and will not receive mepolizumab treatment.

DRUGMepolizumab 100 MG

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

OTHERcombined 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.


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

View Full Details on ClinicalTrials.gov

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NCT07814924


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