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.
Patients with chronic rhinosinusitis with nasal polyps (CRSwNP) and indication for biologic treatment according to the criteria of the EPOS2020 guideline. Presence of bilateral polyps in a patient who had endoscopic sinus surgery (ESS) (except in cases where the patient is not fit for surgery) and three of the following criteria are required: 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. 2. Need for systemic corticosteroids or contraindication to systemic steroids (≥ 2 courses per yr, OR long term (\>3 months) 3. Significantly impaired quality of life (SNOT ≥ 40) 4. Significant loss of smell (VAS). 5. Diagnosis of comorbid asthma
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
75
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.
Hospital de Cruces
Barakaldo, Spain
RECRUITINGHospital de Jerez
Jerez de la Frontera, Spain
RECRUITINGHospital Puerta del Hierro
Madrid, Spain
RECRUITINGHospital de Salamanca
Salamanca, Spain
RECRUITINGHospital universitario Marques de Valdecilla
Santander, Spain
RECRUITINGHospital Universitario Virgen Macarena
Seville, Spain
RECRUITINGHospital de Valladolid
Valladolid, Spain
RECRUITINGthe efficacy of mepolizumab+polypectomy compared to mepolizumab or polypectomy, using the change from baseline in sinonasal outcome test (SNOT-22) total score at week 52.
SNOT-22 total score ranges from 0 to 110, with higher scores indicating worse quality of life/more severe symptoms.
Time frame: 12 moths
Change in nasal polyposis severity VAS score at V1, V6, V12.
VAS score ranges from 0 to 100, with higher scores indicating greater symptom severity.
Time frame: 1 month, 6 months and 12 months
Change in endoscopic nasal polyp score at V1, V6, V12
Time frame: 1 month, 6 months and 12 months
Improvement in individual VAS symptoms (rhinorrhea, mucus in throat, nasal blockage, and sense of smell), patient-reported outcomes at V1, V6, V12
Time frame: 1 month, 6 months and 12 months
Number of patients no longer requiring rescue systemic corticosteroid treatment throughout the first year after the first month of starting the study
Time frame: 12 months
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) Related to Mepolizumab and/or In-office Nasal Polypectomy
Adverse events collected at each study visit and classified as serious or non-serious per protocol definitions, and by causal relationship to treatment (unrelated, possible, probable) as assessed by the investigator.
Time frame: 1 month, 2 months, 4 months, 6 months, 8 months, 10 months and 12 months
Change from baseline in sinonasal outcome test (SNOT-22) total score at weeks 4 and 24
Time frame: 1 month and 12 months
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