Abstract：
AVANT was a Phase 3, 24-week, randomized, parallel-group, double-blind, double-dummy, placebo-controlled study to assess the efficacy and safety of aclidinium/formoterol 400 μg/12 μg combination vs monotherapies and aclidinium vs placebo (1:1:1:1) in Asian patients (∼70% of whom were Chinese) with moderate-to-severe stable chronic obstructive pulmonary disease. Endpoints were analyzed hierarchically to incorporate type I error control. At Week 24, aclidinium/formoterol demonstrated improvements from baseline in 1-h morning post-dose forced expiratory volume in 1 s (FEV1) vs aclidinium (least squares [LS] mean 92 mL; 95% confidence interval [CI] 60, 124 mL; p < 0.001), and in trough FEV1 vs formoterol (LS mean 85 mL; 95% CI 53, 117 mL; p < 0.001). Furthermore, aclidinium provided improvements in trough FEV1 vs placebo (LS mean 134 mL; 95% CI 103, 166 mL; p < 0.001). There was an improvement in transition dyspnea index focal score at Week 24 for aclidinium/formoterol vs placebo (LS mean 0.8; 95% CI 0.2, 1.3; p = 0.005) but not for aclidinium vs placebo (LS mean 0.4; 95% CI -0.1, 1.0; p = 0.132). Improvements in St George\'s Respiratory Questionnaire total scores occurred for aclidinium/formoterol vs placebo (LS mean -4.0; 95% CI -6.7, -1.4; p = 0.003) and aclidinium vs placebo (LS mean -2.9; 95% CI -5.5, -0.3; p = 0.031). Aclidinium/formoterol and aclidinium were well tolerated and safety findings were consistent with known profiles; rates of treatment-emergent adverse events (AEs) (aclidinium/formoterol: 54.8%; aclidinium: 47.4%; placebo: 53.9%), serious AEs (7.2, 7.9, and 7.8%, respectively), and AEs leading to discontinuation of study medication (2.3, 1.5, and 2.2%, respectively) were similar between groups.
摘要：
AVANT是第3阶段，24周，随机化，平行组，双盲,双假人,安慰剂对照研究评估阿地铵/福莫特罗400μg/12μg组合与单药治疗和阿地铵与安慰剂(1:1:1:1)的疗效和安全性亚洲患者(~70%为中国人)患有中度至重度稳定期慢性阻塞性肺疾病.对终点进行分层分析，以纳入I型错误控制。在第24周，阿地铵/福莫特罗在1秒内给药后1小时的用力呼气量（FEV1）与阿地铵（最小二乘[LS]平均92mL；95％置信区间[CI]60,124mL；p<0.001），在FEV1与福莫特罗之间（LS平均85mL；95%CI53，117mL；p<0.001）。此外，与安慰剂相比，阿地铵改善了FEV1的低谷（LS均值134mL；95%CI103，166mL；p<0.001）。在第24周，阿地铵/福莫特罗与安慰剂组的过渡性呼吸困难指数局灶性评分有所改善（LS平均0.8；95％CI0.2，1.3；p=0.005），但阿地铵与安慰剂组没有改善（LS平均0.4；95％CI-0.1，1.0；p=0.132）。阿地溴铵/福莫特罗与安慰剂(LS均值-4.0;95%CI-6.7-1.4;p=0.003)和阿地溴铵与安慰剂(LS均值-2.9;95%CI-5.5,-0.3;p=0.031)的圣乔治呼吸问卷总分有所改善。阿地铵/福莫特罗和阿地铵耐受性良好，安全性发现与已知概况一致；治疗引起的不良事件（AE）发生率（阿地铵/福莫特罗：54.8％；阿地铵：47.4％；安慰剂：53.9％），严重不良事件（7.2、7.9和7.8%，分别)，以及导致研究药物停止的不良事件(2.3、1.5和2.2%，分别)组间相似。
