Status:
UNKNOWN
Establishment of Precise Diagnosis and Treatment System for Refractory Chronic Rhinosinusitis
Lead Sponsor:
Beijing Tongren Hospital
Collaborating Sponsors:
Peking Union Medical College Hospital
Beijing Hospital
Conditions:
Sinusitis
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
Chronic rhinosinusitis that recurs after adequate surgery and conventional medical treatment is called refractory chronic rhinosinusitis (RCRS). Omalizumab and oral glucocorticoid therapy can play an ...
Eligibility Criteria
Inclusion
- (1) Age 18-70 years old;
- (2) All meet the diagnostic criteria of CRS in EPOS2020;
- (3) Patients with asthma were in a stable state, with FEV1 \> 80% of the predicted value or 80% of the optimal value of personal FEV1;
- (4) Good compliance, able to complete clinical observation. Meet the diagnostic criteria for RCRS that the number of eosinophils per high power field in the nasal mucosa is \>55 or the percentage of eosinophils in the tissue is ≥27%;
- (5) Investigator-assessed endoscopic bilateral Nasal Polyp Size Score (NPSS) of 4-6 (minimum score of 2 per nasal cavity);
- (6) Male or eligible female subjects (female subjects not pregnant or breastfeeding);
- (7) Ability to sign an informed consent form, including compliance with the requirements and restrictions outlined in the Informed Consent Form (ICF) and this protocol.
Exclusion
- (1) Medication history of oral glucocorticoids within 3 months before enrollment, glucocorticoid atomization treatment and nasal hormone spray treatment 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, severe nasal septal deviation (Obstruction of one nostril, preventing full evaluation of nasal polyps in both nostrils), undergoing sinus or sinus surgery to alter the structure of the nasal wall resulting in an inability to evaluate the nasal polyp score, persistent drug-induced rhinitis (rebound or chemical-induced rhinitis);
- (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; liver cirrhosis or currently unstable liver or biliary disease as assessed by the investigator;
- (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) Suffering from known, pre-existing, clinically significant cardiac, endocrine, autoimmune, metabolic, neurological, renal, hepatic, hematological or other systemic abnormalities that have not been controlled by standard treatment;
- (10) Patient has been exposed to ionizing radiation above background 10mSv in the past 3 years due to occupational exposure or previous study participation (excluding clinically reasonable therapeutic or diagnostic exposure);
- (11) Women who were pregnant or planned to become pregnant during the study, or who were breastfeeding;
- (12) Subjects who were fertile but were reluctant to use medically approved and effective contraception;
- (13) Those with a history of alcohol or drug abuse;
- (14) Those who had been treated with monoclonal antibodies in the 6 months prior to enrollment;
- (15) Those who believed the patient had other medical or non-medical conditions that were not suitable for the study.
Key Trial Info
Start Date :
May 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT05390255
Start Date
May 25 2022
End Date
December 31 2024
Last Update
May 25 2022
Active Locations (1)
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1
Beijing Tongren Hospital
Beijing, Beijing Municipality, China, 100730