A Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter, Dose-finding, Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of ALC-2203 in Patients With Acute Bronchitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 169
- 试验地点
- 1
- 主要终点
- Change from baseline in Bronchitis Severity Score (BSS) at Day 7
研究概览
简要总结
A Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Multicenter, Dose-finding, Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of ALC-2203 in Patients with 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female participants aged 19 years or older.
- •Patients diagnosed with acute bronchitis with:
- •A Bronchitis Severity Score (BSS) of ≥ 5 at Visit
- •A sputum subscore of at least 1 at Visit
- •Onset of acute bronchitis symptoms within 48 hours prior to Visit
- •Patients who voluntarily agree to participate
排除标准
- •Patients who, in the opinion of the investigator, have severe respiratory diseases such as allergic asthma, chronic bronchitis, or asthma
- •Patients who are currently taking, or are expected to take during the study period, antitussive or expectorant medications containing agents such as codeine or dextromethorphan
- •Patients who have participated in another clinical trial within 4 weeks prior to screening
研究组 & 干预措施
Experimental Group 1
干预措施: ALC-2203-1 (Drug)
Experimental Group 2
干预措施: ALC-2203-2 (Drug)
Active Comparator Group
干预措施: ALC-2203-AC (Drug)
Placebo Comparator Group
干预措施: Placabo (Drug)
结局指标
主要结局
Change from baseline in Bronchitis Severity Score (BSS) at Day 7
时间窗: Baseline (Day 0) to Day 7
The primary outcome measure is the change in total Bronchitis Severity Score (BSS) from baseline (Day 0) to Day 7 following administration of the investigational product. The BSS is a clinician-assessed tool used to evaluate five symptoms: cough, sputum, rales/rhonchi, chest pain during coughing, and dyspnea. Each symptom is scored on a scale from 0 to 4, yielding a total score ranging from 0 to 20.
次要结局
- Change from baseline in Bronchitis Severity Score (BSS) at Day 4(Baseline (Day 0) to Day 4)
- Change from baseline in individual BSS symptom scores at Day 4 and 7(Baseline (Day 0) to Day 4 and Day 7)
- Response rate based on BSS at Day 4 and Day 7(Baseline (Day 0) to Day 4 and Day 7)
- Change from baseline in COAT total score at Day 4 and Day 7(Baseline (Day 0) to Day 4 and Day 7)
- Investigator-assessed overall improvement and treatment effectiveness at Day 4 and 7(Day 4 and Day 7)
- Participant-reported overall satisfaction and satisfaction rate at Days 4 and 7(Day 4 and Day 7)