A Multicenter, Randomized, Double-blinded, Active-controlled, Parallel, Phase III Clinical Trial to Evaluate the Efficacy and Safety of HL301 Versus Umkamin Tab. in Acute Bronchitis Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 246
- 试验地点
- 1
- 主要终点
- Bronchitis Severity Total Score(BSS) Change
研究概览
简要总结
A Multicenter, Randomized, Double-blinded, Active-controlled, Parallel, Phase III Clinical Trial to Evaluate the Efficacy and Safety of HL301 versus Umkamin tab. in acute bronchitis patients
Endpoint: BSS, The improvement and improvement rate of the tester for the treatment response, The satisfaction of the subject
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, Investigator, Outcomes Assessor)
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
- •Both gender, 19 years ≤ age ≤ 80 years
- •(Bronchitis Severity Score)* ≥ 5point at Visit 2 (Randomized Visit)
- •Acute bronchitis within 48hr based on Visit 2 (Randomized Visit)
- •Those who can comply with the requirements of clinical trials
- •Written consent voluntarily to participate in this clinical trial
排除标准
- •Patients with respiratory and systemic infections requiring systemic antibiotic therapy
- •Patients with bleeding tendency
- •Patients who investigators determines to severe respiratory disease that would interfere with study assessment
- •Patients who were treated with oral systemic adrenocortical hormone or immunosuppressive drug within 4 weeks prior to Visit 2
- •Patients who were treated with oral antihistamines, ACE suppressive. or systemic/inhalative glucocorticosteroid within 2 weeks prior to Visit 2
研究组 & 干预措施
HL301(Experimental)
Total 7 days of treatment and The daily dose is as follows [Morning: HL301 1Tab + Placebo of Umkamin 1Tab] [Noon: Placebo of Umkamin 1Tab] [Evening: HL301 1Tab + Placebo of Umkamin 1Tab]
干预措施: HL301(Experimental) (Drug)
Umkamin(Active Comparator)
Total 7 days of treatment and The daily dose is as follows [Morning: Placebo of HL301 1Tab + Umkamin 1Tab] [Noon: Umkamin 1Tab] [Evening: Placebo of HL301 1Tab + Umkamin 1Tab]
干预措施: Umkamin(Active Comparator) (Drug)
结局指标
主要结局
Bronchitis Severity Total Score(BSS) Change
时间窗: Visit 1 (-3 day), Visit 2 (0 day), Visit 3 (7 day)
The BSS comprises the following five symptoms typical for Acute Bronchitis: cough, sputum, rales on auscultation, chest pain on coughing, and dyspnoea. These symptoms are each assessed according to a 5-point Likert scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe and 4 = very severe
次要结局
- The improvement and improvement rate of the tester for the treatment(Visit 3 (7 day))
- The satisfaction of the subject (Questionnaire)(Visit 3 (7 day))