NCT07111468已完成3 期
A Multicenter, Randomized, Double-blind, Parallel, Active-controlled, Superiority, Phase III Clinical Trial to Evaluate the Efficacy and Safety of YHP2401 Compared to YHR2402 and YHR2403 for Acute Bronchitis
Yuhan Corporation11 个研究点 分布在 1 个国家目标入组 286 人开始时间: 2025年8月19日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 286
- 试验地点
- 11
- 主要终点
- Bronchitis Severity Score(BSS)
研究概览
简要总结
A Multicenter, Randomized, Double-blind, Parallel, Active-controlled, Superiority, Phase III Clinical Trial to Evaluate the Efficacy and Safety of YHP2401 Compared to YHR2402 and YHR2403 for Acute Bronchitis
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female participants 19 years ≤ age ≤ 80 years
- •Patients with acute bronchitis presenting with productive cough symptoms within 48 hours prior to Visit 2 (Baseline)
- •BSS total score ≥ 5 at Visit 2, including Cough score ≥ 2, Sputum score ≥ 1
- •Patients who voluntarily signed the consent form
排除标准
- •Severe lung disease as determined by the investigator
- •Clinically significant abnormal findings or signs on chest X-ray suggesting diagnoses other than acute bronchitis
- •Active infection requiring systemic antibiotic treatment
- •Patients who need to take contraindicated concomitant medications
研究组 & 干预措施
YHP2401
Experimental
干预措施: YHP2401 (Drug)
YHR2402
Active Comparator
干预措施: YHR2402 (Drug)
YHR2403
Active Comparator
干预措施: YHR2403 (Drug)
结局指标
主要结局
Bronchitis Severity Score(BSS)
时间窗: Day 4
次要结局
未报告次要终点
研究者
研究点 (11)
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