[Translation] A multicenter, randomized, double-blind, placebo-controlled phase II clinical trial to evaluate the efficacy and safety of XH-S004 tablets in patients with non-cystic fibrosis bronchiectasis
主要目的:评价不同剂量XH-S004对支扩患者发生急性加重时间的影响。
次要目的
1. 评价不同剂量XH-S004对支扩患者的急性加重发生率,肺功能测试第1秒用力呼气容积(FEV1),以及QoL-B RSS问卷评分的影响;
2. 评价不同剂量XH-S004在支扩患者中的药代动力学(PK)特征;
3. 评价不同剂量XH-S004对支扩患者痰液中活性中性粒细胞弹性蛋白酶(NE)浓度的影响;
4. 评价不同剂量XH-S004在支扩患者中的安全性。
[Translation] Primary objective: To evaluate the effect of different doses of XH-S004 on the time of acute exacerbation in patients with bronchiectasis.
Secondary objectives
1. To evaluate the effect of different doses of XH-S004 on the incidence of acute exacerbation, forced expiratory volume in 1 second (FEV1) of lung function test, and QoL-B RSS questionnaire score in patients with bronchiectasis;
2. To evaluate the pharmacokinetic (PK) characteristics of different doses of XH-S004 in patients with bronchiectasis;
3. To evaluate the effect of different doses of XH-S004 on the concentration of active neutrophil elastase (NE) in sputum of patients with bronchiectasis;
4. To evaluate the safety of different doses of XH-S004 in patients with bronchiectasis.