CST1-Guided Oral Glucocorticoids Management for CRSwNP (COMPASS)

This is an interventional treatment trial for Chronic Rhinosinusitis With Nasal Polyps Read More

Inclusion Criteria:

1. Age 18-70 years old；
2. All meet the diagnostic criteria of CRSwNP in EPOS2020;
3. Investigator-assessed endoscopic bilateral Nasal Polyp Size Score (NPSS) was greater than or equal to 4 (minimum score of 2 per nasal cavity);
4. Patients with asthma were in a stable state, with FEV1 > 50% of the predicted value or 50% of the optimal value of personal FEV1; (5) Good compliance, able to complete clinical observation.

Exclusion Criteria:

1. Medication history of oral glucocorticoids within 3 months before enrollment, antibiotics within 2 weeks;
2. Oral glucocorticoid contraindications, such as diabetes, femoral head necrosis, gastric ulcer, etc.;
3. Any nasal and/or sinus surgery within 3 months before enrollment;
4. Patients have conditions or comorbidities that may preclude evaluation of the primary efficacy endpoint, such as: unilateral posterior nasal polyp of maxillary sinus, acute rhinitis, nasal infection or upper respiratory tract at the screening period or within 2 weeks before the screening period infection, acute asthma attack within 4 weeks, current drug-induced rhinitis, allergic fungal sinusitis (AFRS), benign or malignant tumor of nasal cavity；
5. Important clinical comorbidities that may interfere with clinical effectiveness, including but not limited to: active upper or lower respiratory tract infection, cystic fibrosis, eosinophilic granuloma with polyvasculitis (Churg-Strauss syndrome), granulomatosis with polyangiitis (Wegener's granulomatosis), Young's syndrome, etc.;
6. Accompanying serious diseases or recurrent chronic diseases with poor systemic control, such as (but not limited to), active infection, cardiovascular disease, tuberculosis or other pathogen infection, diabetes, autoimmune disease, HIV, hepatitis B, Hepatitis C or parasitic diseases, malignant tumors, etc.;
7. Subjects with severe liver and kidney function injury; such as, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) >2 times the upper limit of normal, serum creatinine > the upper limit of normal value;
8. Known or suspected immunosuppression, including a history of invasive opportunistic infections (such as tuberculosis, histoplasmosis, listeriosis, coccidioidomycosis, pulmonary cysts, aspergillosis), even if the infection has subsided;
9. Women who were pregnant or planned to become pregnant during the study, or who were breastfeeding;
10. Subjects who were fertile but were reluctant to use medically approved and effective contraception;
11. Those with a history of alcohol or drug abuse;
12. Those who believed the patient had other medical or non-medical conditions that were not suitable for the study.