A Randomized, Double-blind, Active-controlled, Parallel-group, Multicenter, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of AG2001 in Patients With Acute Bronchitis
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 主要终点
- Change in Bronchitis Severity Score (BSS) from Baseline to Day 4
研究概览
简要总结
This is a Phase 3, randomized, double-blind, active-controlled clinical trial designed to evaluate the efficacy and safety of AG2001 in patients with acute bronchitis. The primary objective is to demonstrate the superiority of AG2001 over two active comparators based on the change in Bronchitis Severity Score (BSS) at Day 4.
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
- 19 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged ≥19 years to <65 years old
- •Subjects who present symptoms of Acute Bronchitis with cough and sputum symptoms within 48 hours prior the randomization visit(Visit 2) who satisfy the following
- •Total Bronchitis Severity Scale ≥ 5
- •Total Bronchitis Severity Scale sputum score ≥ 2
- •Subjects who without fever(condensed body temperature standard: less than 38.5°C) prior to randomization visit(Visit 2)
- •Subjects who present symptoms of Acute Bronchitis with cough less then 2 weeks prior to randomization visit(Visit 2)
- •Written consent voluntarily to participate who can understand the information provided in this clinical trial
排除标准
- •Chronic respiratory diseases (e.g., COPD, asthma, pneumonia, tuberculosis, lung cancer)
- •Clinically significant hepatic, renal, cardiovascular, or neurological disorders
- •Use of prohibited medications (e.g., antibiotics, antivirals, corticosteroids) within the washout period
- •Positive test for hepatitis B, hepatitis C, or HIV
- •Pregnant or breastfeeding women
- •Any condition deemed inappropriate by the investigator
研究组 & 干预措施
AG2001
Participants receive AG2001 with matching placebos, administered orally three times daily for 7 days.
干预措施: AG2001 (Drug)
AG20011
Participants receive AG20011 with matching placebos, administered orally three times daily for 7 days.
干预措施: AG20011 (Drug)
AG20012
Participants receive AG20012 with matching placebos, administered orally three times daily for 7 days.
干预措施: AG20012 (Drug)
结局指标
主要结局
Change in Bronchitis Severity Score (BSS) from Baseline to Day 4
时间窗: Baseline to Day 4
The difference in BSS total score compared between treatment and comparator groups.
次要结局
- Change in BSS Subscale Scores (cough, sputum, etc.) at Day 4 and Day 7(Baseline to Day 4 and Day 7)
- Change in Bronchitis Severity Score (BSS) from Baseline to Day 7(Baseline to Day 7)
- Proportion of BSS Responders at Day 4 and Day 7(Baseline to Day 4 and Day 7)
- Change in Integrative Medicine Outcome Scale (IMOS)(Baseline to Day 4 and Day 7)
- Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)(Up to 30 days after last dose)
- Change in Integrative Medicine Patient Satisfaction Scale (IMPSS)(Baseline to Day 4 and Day 7)