The purpose of this study is to evaluate the Pharmacodynamic, Efficacy and Safety of SHR-1703 in Asthma Patients with Eosinophil Phenotype
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
400
West China School of Medicine West China Hospital of Sichuan University
Chengdu, Sichuan, China
RECRUITINGAnnualised asthma exacerbation rate,about 48weeks
Time frame: about 48weeks
Mean number of days with oral corticosteroids taken for exacerbation,about 48weeks
Time frame: about 48weeks
Frequency of exacerbations requiring hospitalisation,about 48weeks
Time frame: about 48weeks
Time to first exacerbation requiring hospitalisation,about 48weeks
Time frame: about 48weeks
Mean change from baseline in clinic pre- and post-BD FEV1,about 64 weeks
Time frame: about 64 weeks
Mean change from baseline in clinic pre- and post-BD FEV1%,about 64weeks
Time frame: about 64weeks
Mean change from baseline in clinic pre- and post-BD FVC,about 64 weeks
Time frame: about 64 weeks
Mean change from baseline in clinic pre- and post-BD PEF,about 64 weeks
Time frame: about 64 weeks
Mean change from baseline in FeNO,about 64weeks
Time frame: about 64weeks
Mean change from baseline in asthma control questionnaire (ACQ-6) score,about 64 weeks
Time frame: about 64 weeks
Mean change from baseline in ASTHMA QUALITY OF LIFE QUESTIONNAIRES (AQLQ) score,about 64weeks
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Time frame: about 64weeks
Mean change from baseline in Asthma symptom score at week 12/24/36/48/60,about 64weeks
Time frame: at week 12/24/36/48/60,about 64weeks
Mean change from baseline in daily rescue medication use at week 12/24/36/48/60,about 64weeks
Time frame: at week 12/24/36/48/60,about 64weeks
Mean change from baseline in awakening at night due to asthma symptoms requiring rescue medication use at week 12/24/36/48/60,about 64weeks
Time frame: at week 12/24/36/48/60,about 64weeks
Mean change from baseline in morning and evening PEF at week 12/24/36/48/60,about 64weeks
Time frame: at week 12/24/36/48/60,about 64weeks
Mean change from baseline in IgE,about 64weeks
Time frame: about 64weeks
Adverse events,about 64weeks
Time frame: about 64weeks