NCT06038084已完成4 期
A Prospective, Multi-center, Active-control, Parallel Group, Randomized, Double-blinded, Non-inferiority Investigator Initiative Clinical Trial to Evaluate the Efficacy and Safety of Acute Bronchitis Symptoms Improvement for Bronpass Tab. Compared to Erdos Capsule on Patients With Acute Bronchitis
Kwang-Ha Yoo1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2022年4月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Change in BSS(Bronchitis severity score) total score
研究概览
简要总结
The purpose of this clinical trial is to evaluate the acute bronchitis symptom relief effect of Bronpass tab. compared to Erdos capsule, and compare and evaluate the safety.
详细描述
The purpose of this clinical trial is to evaluate the following in patients with acute bronchitis at the 7th day of administration of the investigational drug.
primary purpose: Prove the non-inferiority of the acute bronchitis symptom relief effect of Bronpass tab. compared to Erdos capsule, and compare and evaluate the safety.
secondary purpose: Compare and evaluate the effect of improving clinical symptoms, including sputum symptoms, of Bronpass tab. compared to Erdos capsule.
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
- •Adult aged 19 to 80 at the time of screening
- •Patients with an acute bronchitis severity score (BSS) of 5 or higher at the time of screening and the first day of administration of the investigational drug
- •Patients with symptoms of acute bronchitis within 48 hours from the time of screening
- •Patients who voluntarily gave written consent to participate in this clinical trial
排除标准
- •Patients with a known hypersensitivity reaction to the components of this investigational product
- •Patients with respiratory and systemic infections requiring systemic antibiotic treatment
- •Patients with clotting disorders or bleeding tendencies
- •Patients with peptic ulcer at the time of screening
- •Severe lung diseases that may affect the efficacy evaluation of this clinical trial at the discretion of the investigator
- •For screening test results, creatinine clearance < 25 mL/min or AST, ALT more than 3 times the upper limit of normal
- •A person who have administered systemic corticosteroids or immunosuppressants within 4 weeks of the first administration of the investigational drug
- •A person who have administered antiviral drugs, systemic/inhaled glucocorticosteroids within 48 hours of the first administration of investigational drugs
- •A person who have administered mucolytics, sputum discharge agents, antitussives, herbal medicines with antitussive/ expectorant effects, and antihistamines within 48 hours of the first administration of investigational drugs
- •A person who need or plan to take contraindicated drugs or therapies during this clinical trial period
- •Patient with liver cirrhosis or cystathionine synthetase deficiency
- •Patient who have clinically significant diseases and disorders in the cardiovascular system, endocrine system, and central nervous system at the time of screening, or who have a history of malignant tumors or mental disorders (eg. depression) (However, participation is possible if there is no recurrence for more than 5 years after surgery at the time of screening)
- •A person with a history of alcoholism or drug abuse
- •Heavy smokers (more than 15 cigarettes per day) within 4 weeks from the time of screening
- •Pregnant or lactating
- •Among female subjects of childbearing potential, women who do not intend to use appropriate contraceptive methods or plan to become pregnant during this clinical trial
- •A person who administered other investigational drugs within 4 weeks from the time of screening
- •A person who are not suitable for participation in this clinical trial under the judgment of the investigator
研究组 & 干预措施
Bronpass Tab.
Experimental
干预措施: Bronpass Tab. (Drug)
Bronpass Tab.
Experimental
干预措施: Placebo of Erdos capsule (Drug)
Erdos capsule
Active Comparator
干预措施: Erdos capsule (Drug)
Erdos capsule
Active Comparator
干预措施: Placebo of Bronpass Tab. (Drug)
结局指标
主要结局
Change in BSS(Bronchitis severity score) total score
时间窗: Visit 3 (Day 7)
Change in BSS(Bronchitis severity score) total score at 7 days after administration of investigational drug compared to baseline \* The total BSS score ranges from 0 to 20, with higher scores indicating greater severity of symptoms.
次要结局
- Number of rescue drug doses(Visit 3 (Day 7))
- Changes in inflammatory marker (CRP in mg/L) at 7 days after administration of investigational drugs compared to baseline(Visit 3 (Day 7))
- Changes in inflammatory marker (TNF-α in pg/mL) at 7 days after administration of investigational drugs compared to baseline(Visit 3 (Day 7))
- Overall improvement as assessed by the investigator using the investigator's overall improvement evaluation sheet (5-point scale)(Visit 3 (Day 7))
- Changes in inflammatory marker (IL-6 in pg/mL) at 7 days after administration of investigational drugs compared to baseline(Visit 3 (Day 7))
- Change in BSS(Bronchitis severity score) score by symptom (cough, sputum, dyspnea, chest pain when coughing, crackles/rhonchus)(Visit 3 (Day 7))
- Changes in inflammatory marker (IL-1β in pg/mL) at 7 days after administration of investigational drugs compared to baseline(Visit 3 (Day 7))
- Satisfaction evaluated by the subject using the subject's satisfaction evaluation sheet (5-point scale)(Visit 3 (Day 7))
研究者
Kwang-Ha Yoo
Professor
Konkuk University Medical Center
研究点 (1)
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