NCT06411925招募中4 期
A Multi-center, Randomized, Double-blinded, Active-controlled, Non-inferiority, Phase 4 Trial to Evaluate the Efficacy and Safety of Atock Dry Syrup Sama With Acute Bronchitis Patients
SamA Pharmaceutical Co., Ltd1 个研究点 分布在 1 个国家目标入组 296 人开始时间: 2023年11月10日最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 296
- 试验地点
- 1
- 主要终点
- The rate of subjects whose symptoms improved based on the wheezing score at 3 days
研究概览
简要总结
Clinical Study to Evaluate the Efficacy and Safety of Atock Dry Syrup with Acute bronchial Patients
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
- 6 Months 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged ≥6 months to <12 years old
- •Total Bronchitis Severity Scale excluding sputum(BSSEs) ≥4
- •Wheezing score ≥2
- •Subjects who present symptoms of Acute Bronchitis within 48 hours from screening visit
- •Subject with negative results in HbsAg or HCV Ab test within 6 months from screening visit
排除标准
- •Subjects with chronic respiratory diseases (e.g., asthma, COPD) or severe respiratory diseases (e.g., pneumonia, cystic fibrosis, influenza, active tuberculosis)
- •Subjects under treatment with corticosteroids, antibiotics medications
- •Subjects with severe hepatic and renal impairment
- •Subjects with a history of drug abuse
- •Subject with positive results in HIV Ab test
研究组 & 干预措施
Atock Dry Syrup
Experimental
干预措施: Atock Dry Syrup with placebo patch (Drug)
tulobuterol patch
Active Comparator
干预措施: Tulobuterol patch with placebo dry syrup (Drug)
结局指标
主要结局
The rate of subjects whose symptoms improved based on the wheezing score at 3 days
时间窗: 3 days treatment period
The rating was: 0=No wheezing (None); 1=mild (End expiration with stethoscope); 2=moderate (Inspiration and expiration with stethoscope) and 3=severe (Audible without stethoscope).
次要结局
- The change in patient satisfaction scores for wheezing (VAS, Visual Analogue Scale) at 3 and 7 days(3 and 7 days treatment period)
- The change in bronchitis severity score excluding the sputum (BSSEs) at 3 and 7 days(3 and 7 days treatment period)
- The rate of subjects whose wheezing score improved by two or more grades at 3 and 7 days(3 and 7 days treatment period)
- The rate of subjects whose symptoms improved based on the wheezing score at 7 days(7 days treatment period)
- The change in patient satisfaction scores for cough (COAT, COugh Assessment Test) at 3 and 7 days(3 and 7 days treatment period)
研究者
研究点 (1)
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