Asthma Clinical Trial
Official title:
A Randomized, Double-blind, Head-to-head Comparison of Dupilumab Versus Omalizumab in Severe Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) and Comorbid Asthma Patients
Primary Objective -To evaluate the efficacy of dupilumab compared to omalizumab in reducing the polyp size and improving sense of smell Secondary Objectives - To evaluate the efficacy of dupilumab in improving CRSwNP symptoms at Week 24 compared to omalizumab - To evaluate the efficacy of dupilumab in improving lung function at Week 24 compared to omalizumab - To evaluate the efficacy of dupilumab in improving CRSwNP total symptom score (TSS) at Week 24 compared to omalizumab - To evaluate the effect of dupilumab on health related quality of life (HRQoL) at week 24 compared to omalizumab - To evaluate the efficacy of dupilumab in improving nasal peak inspiratory flow at Week 24 compared to omalizumab - To evaluate the effect of dupilumab on CRSwNP overall disease severity at Week 24 compared to omalizumab - To evaluate the effect of dupilumab on asthma control at Week 24 compared to omalizumab - To evaluate the safety of dupilumab and omalizumab
Study duration per participant will be 38 weeks. The study will comprise 3 periods: 28 days ± 3 days screening and run-in period; 24 weeks Randomized investigational medicinal product (IMP) intervention period; up to 12 weeks follow-up period. ;
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