KCT0001239已完成未知
A phase II, multicenter, randomized, double-blind, parallel group study to determine the optimal dose of HL301 after 7 days oral administration in acute bronchitis or acute exacerbations of chronic bronchitis patients.
Hanlim Pharmaceutical0 个研究点目标入组 156 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 156
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 80(Year)（—）
- 性别
- All
入选标准
- •1. both gender, 19 years = age = 80 years
- •2. acute bronchitis or acute exacerbations of chronic bronchitis patients with BSS(Bronchitis Severity Score)* = 5point at Visit1 and Visit2
- •3. Written consent voluntarily to participate in this clinical trial
排除标准
- •1. Patients who were increased the bleeding tendency
- •2. Patients with any of ALT, AST or serum BUN, Creatinine> 2 times of the normal upper range
- •3. Patients who investigators determines to severe respiratory disease that would interfere with study assessment
- •4. Patients with COPD history of stage 3 or more
- •5. Patients who were treated with oral systemic adrenocortical hormone or immunosuppressive drug whithin 4 weeks prior to study participation
- •6. Patients who were treated with oral ß2-agonist, anticholinergic, Methylxanthine, antibiotics, antihistamines, sympathomimetic agent or oriental medicine/health functional food for antitussive and mucolytic Effect whithin 1 weeks prior to study participation
- •7. Patients who were treated with oral Antitussive, Mucolytic Agents,systemic antimicrobial agent whithin 3 days prior to study medication dosing
- •8. Patients with drug or alcohol abuse
- •9. Patients with clinically significant active liver, renal, cardiovascular, respiratory, endocrine, central nervous system disease or history of malignant tumor or mental illness(except no relapse for 5 years after surgery)
- •10. The aged person with severe medical history which is mental disorder(dementia), cancer, chronic renal failure, chronic liver failure
- •11. Pregnant or breast-feeding
- •12. Patients currently participating in or has participated in other clinical study within 30 days prior to study participation
- •13. Patients who investigators determines not appropriate to take part in this clinical study
研究者
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