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.
Instituto de Investigación Marqués de Valdecilla
75 participants
Dec 31, 2024
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
Plain Language Summary
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Interventions
polypectomy in the office and will not receive mepolizumab treatment.
will not undergo in-office nasal polypectomy and will start treatment with mepolizumab directly after randomization.
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)
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NCT07814924