Randomized, Double-blind, Placebo/Active-controlled, Multi-center, Phase 3 Clinical Trial to Investigate the Safety/Tolerability and Efficacy of YHD001 After Oral Administration in Patients With Acute or Chronic Bronchitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- Change of total symptom score from baseline to the end of treatment
研究概览
简要总结
The study will conduct with 4 comparative groups orally treated with YHD001 dose level 1(t.i.d.), YHD001 dose level 2(t.i.d.), pelargonium sidoides extract 9mL(t.i.d.) or Placebo for 7 days.
The treatments will be assigned randomly to patients (n=116) with acute or chronic bronchitis.
详细描述
The outcome measures is to evaluate the overall change from baseline to the end of treatment in scores relating to the severity of four symptom of bronchitis: cough, sputum, QOL of daily life, QOL of falling asleep at night.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients aged ≥18 year
- •Provision of written informed consent
- •Acute bronchitis with a Bronchitis Severity Score(BSS)≥five points
排除标准
- •History of any clinically significant disease
- •History of drug/chemical/alcohol abuse
- •Use of antibiotics, anti-histamine during the 7 days before administration of the investigational product
研究组 & 干预措施
YHD001 dose level 1
YHD001 dose level 1
干预措施: YHD001 dose level 1 (Drug)
YHD001 dose level 2
YHD001 dose level 2
干预措施: YHD001 dose level 2 (Drug)
Pelargonium sidoides extract
Pelargonium sidoides extract (Syrup)
干预措施: Pelargonium sidoides extract (Drug)
Placebo
Placebo for YHD001 & active comparator(syrup)
干预措施: placebo (Drug)
结局指标
主要结局
Change of total symptom score from baseline to the end of treatment
时间窗: 7 days
次要结局
- safety assessment(7 days)
- time to response(7 days)
- compliance, defined by drug accountability(7 days)