NCT02792946已完成3 期
Compare the Efficacy and Safety of Surfolase CR Tablet With Surfolase Capsule in Patients With Acute Bronchitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 244
- 主要终点
- Change from Baseline in baseline to Day 7 for total number of Bronchitis Severity Score (BSS)
研究概览
简要总结
Compare the efficacy and safety of surfolase CR tablet with surfolate capsule 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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 19 to 65 years, inclusive
- •Patients with acute bronchitis which is accompanied with a cough which includes sputum within 48 hours and has over 5 for Bronchitis severity score (BSS) at Screening
- •Patients who agreed to participate clinical trial and sign on informed consent form
排除标准
- •Patients who are suspicious or diagnosed for pneumonia
- •Patients with chronic bronchitis, Chronic Obstructive Pulmonary Disease (COPD), bronchiolitis, asthma, bronchial asthma
- •Patients with active infection who needs administration of antibiotics
- •Patients with myocardial infarction, congestive heart failure
- •Patients with renal disorder or liver disorder
- •Patients with hypotension or hypertension
- •Patients with history of epilepsy
- •Patients with hyperthyroidism
- •Patients with gastroduodenal ulcer
- •Patients with sever hypoxemia
- •Patients who are in drug or therapy or planned to have;
- •antibiotics, anti-virus, angiotensin converting enzyme (ACE) inhibitor and systemic or inhalation glucocorticosteroids: from 2 weeks prior to administration of investigational product to termination of clinical trial
- •Angiotension II receptor blocker (ARB), secretolytics/mucolytics, expectorants, antitussives, a herb medicines which has antitussive or expectorant effect: from 2 days prior to administration of investigational product to termination of clinical trial
- •Analgesics except acetaminophen, antihistamines, β2-agonists, bronchodilators which includes anticholinergic agents, xanthine derivatives, central nervous system stimulants, drug which is known for interaction between acebrophylline (cimetidine, alloprinol, oral anticoagulants, furosemide, reserpine, barbiturates, phenytoin) and symtomatic therapy for other therapy for acute bronchitis: whole period for clinical trial
- •Patients who has history for drug hypersensitivity or allergic reaction in component of investigational product or similar drug
- •Patients with pregnant and/or have breast feeding.
- •Patients with no intention to use appropriate contraceptives or has a plan to become pregnant
- •Patients who had an administrationb of other investigational product or medical device for clinical trial 4 weeks prior to participation of clinical trial
- •Patients who are identified as inappropriate by other investigators to participate clinical trial
研究组 & 干预措施
Sulfolase CR (200mg, QD)
Experimental
for 7 days with or without meal
干预措施: Acebrophylline (Drug)
Sulfolase Capsule (100mg, BID)
Active Comparator
for 7 days with or without meal
干预措施: Acebrophylline (Drug)
结局指标
主要结局
Change from Baseline in baseline to Day 7 for total number of Bronchitis Severity Score (BSS)
时间窗: Baseline, At Day 7
次要结局
- Change from Baseline in baseline to Day 7 for number of BSS per symptom(Baseline, At Day 7)
- Response rate at Day 7(Baseline, At Day 7)
研究者
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