Preventative Omalizumab or Step-up Therapy for Severe Fall Exacerbations (PROSE/ICAC-20)

A three-armed prospective randomized double-blind placebo-controlled trial investigating the efficacy of standard care plus 4-5 months of treatment with (a) a boost of inhaled corticosteroid therapy Flovent Diskus (fluticasone) versus (b) Xolair(omalizumab) or (c) placebo Xolair (omalizumab) and placebo Flovent Diskus (fluticasone) in reducing the exacerbations during the fall season.

本研究为一项三臂前瞻性随机双盲安慰剂对照试验，旨在评估标准治疗联合4至5个月的三类干预措施在秋季减少疾病急性加重的疗效，三类干预分别为：(a) 吸入性糖皮质激素增量治疗方案——氟替卡松碟式吸入剂（Flovent Diskus，通用名：氟替卡松fluticasone）；(b) 奥马珠单抗（Xolair，omalizumab）；(c) 奥马珠单抗安慰剂联合氟替卡松碟式吸入剂安慰剂。