[Translation] A randomized, double-blind, placebo-controlled, parallel design phase II clinical trial evaluating the efficacy and safety of QR052107B tablets in patients with subacute cough
主要目的:
1、以24小时内平均每小时咳嗽次数为指标,评估D10时QR052107B片相对于安慰剂在亚急性咳嗽患者中的疗效。
次要目的:
1、在基线期24小时内平均每小时咳嗽次数≥20次的亚急性咳嗽患者中,以24小时内平均每小时咳嗽次数为指标,评估D4、D10时QR052107B片相对于安慰剂的疗效。
2、以24小时内平均每小时咳嗽次数为指标,评估D4时QR052107B片相对于安慰剂在亚急性咳嗽患者中的疗效。
3、以清醒时平均每小时咳嗽次数为指标,评估D4、D10时QR052107B片相对于安慰剂在亚急性咳嗽患者中的疗效。/4、以咳嗽严重程度VAS评分为疗效指标,评估D4、D10时QR052107B片相对于安慰剂在亚急性咳嗽患者中的疗效。
4、以莱切斯特咳嗽评分为指标,评估D4、D10时QR052107B片相对于安慰剂在亚急性咳嗽患者中的疗效。
5、以睡眠VAS评分为指标,评估D4、D10时QR052107B片相对于安慰剂的疗效。
6、评估QR052107B片在亚急性咳嗽患者中的安全性和耐受性。
[Translation] main purpose:
1. Taking the average number of coughs per hour within 24 hours as an index, evaluate the efficacy of QR052107B tablets compared with placebo in patients with subacute cough on D10.
Secondary purpose:
1. In the subacute cough patients with an average cough times ≥ 20 times per hour within 24 hours in the baseline period, use the average cough times per hour within 24 hours as an index to evaluate the efficacy of QR052107B tablets compared with placebo on D4 and D10.
2. Taking the average number of coughs per hour in 24 hours as an index, evaluate the efficacy of QR052107B tablets compared with placebo in patients with subacute cough at D4.
3. Taking the average number of coughs per hour when awake as an index, evaluate the efficacy of QR052107B tablets compared with placebo in patients with subacute cough at D4 and D10. /4. Taking the cough severity VAS score as the efficacy index, evaluate the efficacy of QR052107B tablets compared with placebo in patients with subacute cough at D4 and D10.
4. Using the Leicester cough score as an index, evaluate the efficacy of QR052107B tablets compared with placebo in patients with subacute cough at D4 and D10.
5. Using sleep VAS score as an index, evaluate the efficacy of QR052107B tablets compared with placebo on D4 and D10.
6. To evaluate the safety and tolerability of QR052107B tablets in patients with subacute cough.