Study Regarding the Clinical Efficacy of Synatura® in Patients With Chronic Bronchitis Type COPD
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- COPD assessment test (CAT)
研究概览
简要总结
This study aims to examine the clinical efficacy of synatura in patients with chronic bronchitis type COPD in Korea.
详细描述
Synatura® is a drug commonly used to suppress cough and sputum in patients with acute upper respiratory tract infection and chronic inflammatory bronchitis. According to the Phase III studies conducted in Korea, the safety and efficacy of Synatura® on antitussive and expectorant effects were confirmed in patients with acute upper respiratory infection and chronic inflammatory bronchitis. However, no studies have been conducted for the effects of Synatura® in patients with COPD. COPD is divided into emphysema type and chronic bronchitis type, while typical clinical symptoms of chronic bronchitis are cough and sputum. Therefore, Synatura®, which is effective for chronic bronchitis, is expected to be effective in patients with chronic bronchitis accompanied by COPD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Post bronchodilator FEV1/FVC < 0.7
- •Smoking history of ≥10 packs per year
- •40 to <75 years of age
- •Patients with symptoms of chronic bronchitis (in case they have symptoms of cough or sputum over 3 months)
排除标准
- •Patients with acute exacerbation
- •Patients with pneumonia
- •Patients with active tuberculosis
- •Pregnant women
- •Breast-feeding women
- •Patients with fructose intolerance
研究组 & 干预措施
Synatura® 15 mL
Synatura syrup single arm
干预措施: Synatura® 15 mL (Drug)
结局指标
主要结局
COPD assessment test (CAT)
时间窗: Baseline, At 12weeks
Change from Baseline in baseline to 12 weeks for COPD assessment test (CAT)
次要结局
- Efficacy of pulmonary function in bronchitis type COPD patients(Baseline, At 12weeks)
- Total number of Bronchitis Severity Score (BSS)(Baseline, At 12weeks)
- Efficacy of inflammation throughout the body in bronchitis type COPD patients(Baseline, At 12weeks)