Available datapackage for study 'A Phase IIIb Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Xolair in Subjects With Moderate to Severe Persistent Asthma Who Are Inadequately Controlled With High-Dose Inhaled Corticosteroids and Long-Acting Beta-Agonists'

This is a multicenter, randomized, double-blind, placebo-controlled study of the efficacy, safety, and tolerability of subcutaneously administered Xolair as add-on therapy for the treatment of subjects aged 12-75 years old diagnosed with moderate to severe asthma who are inadequately controlled with high-dose inhaled corticosteroids (ICS)+ long-acting beta-agonists (LABA) with or without additional controller therapy.

本研究为一项多中心、随机、双盲、安慰剂对照研究，旨在评估皮下给药的Xolair作为附加疗法，用于治疗经大剂量吸入性糖皮质激素（inhaled corticosteroids, ICS）联合长效β₂受体激动剂（long-acting beta-agonists, LABA）（伴或不伴其他控制治疗）控制不佳的12~75岁确诊中重度哮喘受试者的疗效、安全性与耐受性。