Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) and Severe Eosinophilic Asthma
Conditions
Interventions
Group A: Continued Mepolizumab:Mepolizumab
Group D: Standard Maintenance:Mepolizumab Q4W
Group B: Switch to Stapokibart:Stapokibart
Group E: Reduced-Frequency Maintenance:Mepolizumab Q8W
Group C: Combination Therapy:Mepolizumab + Dupilumab
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >=18 years; 2. Diagnosis of CRSwNP according to EPOS 2023 criteria; 3. Bilateral nasal polyp score (NPS) >=4, with a unilateral score >=2; 4. Confirmed diagnosis of asthma within the past 1 year, based on clinical manifestations and relevant objective examinations (GINA 2025): (1) Presence of variable respiratory symptoms, including wheezing, chest tightness, dyspnea, and cough, with temporal variability (worsening at night/early morning), trigger-related variability (induced by allergens, cold air, exercise, etc.), or relief-related variability (improvement after inhaled SABA); (2) Objective evidence of variable expiratory airflow limitation, meeting at least one of the following criteria in adults/adolescents: positive bronchodilator reversibility test, or diurnal peak expiratory flow (PEF) variability meeting the specified threshold; (3) Exclusion of other diseases that may cause similar symptoms, such as COPD, bronchiectasis, or gastroesophageal reflux disease (GERD); (4) Positive bronchial provocation test or bronchodilator reversibility test. 5. Positive eosinophilic inflammatory biomarker (meeting at least one of the following criteria): (1) Peripheral blood eosinophil count >=150/µL;(2) Sputum eosinophil percentage >=3% (preferred when available;considered the gold standard);(3) Fractional exhaled nitric oxide (FeNO) >=50 ppb in ICS-naïve patients, or >=25 ppb in patients on medium- to high-dose ICS; 6. Signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Cystic fibrosis-related sinusitis; 2. Primary ciliary dyskinesia; 3. Fungal sinusitis; 4. Lower airway diseases that may significantly affect the diagnosis of asthma or the evaluation of treatment efficacy, including but not limited to COPD, bronchiectasis, active pulmonary tuberculosis, and interstitial lung disease; 5. Active infections, including but not limited to acute respiratory tract infection, uncontrolled chronic infection, active tuberculosis, active parasitic infection, or any other infectious state deemed by the investigator to be unsuitable for biologic therapy; 6. Known severe hypersensitivity to mepolizumab, stapokibart, or any of their excipients; 7. Active malignancy; 8. Pregnancy or breastfeeding; 9. Prior receipt of biologic therapy within the past 1 year; 10. Any condition that, in the investigator's judgment, makes the patient unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Nasosinusitis Response Rate at Week 12; | — |
Secondary
| Measure | Time frame |
|---|---|
| Asthma Control Test (ACT) Score;Forced Expiratory Volume in One Second (FEV1);Sino-Nasal Outcome Test-22 Score;Nasal Polyp Score;Blood Eosinophil Count; | — |
Countries
China
Contacts
Public ContactLiu Feng
West China Hospital of Sichuan University
Outcome results
None listed