This randomized, controlled multicenter trial will recruit patients aged 18 to 70 7 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 different 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
75
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
This group will undergone in-office nasal polypectomy.
Hospital de Curces
Bilbao, Spain
Hospital de Jerez
Jerez de la Frontera, Spain
Hospital Puerta del Hierro
Madrid, Spain
HUCA
Oviedo, Spain
Hospital Universitario Marques de Valdecilla
Santander, Spain
Hospital Virgen Macarena
Seville, Spain
Hospital Valladolid
Valladolid, Spain
Mepolizumab+polypectomy compared to mepolizumab or polypectomy, using the change from baseline in sinonasal outcome test (SNOT-22) total score
Time frame: up to 52 weeks
Change in nasal polyposis severity VAS score at 4 weeks, 6 months, 12 months
Time frame: up to 52 weeks
Change in endoscopic nasal polyp score at 4 weeks, 6 months, 12 months
Time frame: up to 52 weeks
Improvement in individual VAS symptoms (rhinorrhea, mucus in throat, nasal blockage, and sense of smell), patient-reported outcomes at 4 weeks, 6 months, 12 months
Time frame: up to 52 weeks
Number of patients no longer requiring rescue systemic corticosteroid treatment throughout the first year after the first month of starting the study
Time frame: up to 52 weeks
Number of participants with mepolizumab and in-office nasal polypectomy related adverse events
Time frame: up to 52 weeks
Change from baseline in sinonasal outcome test
The minimum value is 0 and maximum value is 110
Time frame: up to 4 and 24 week
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