NCT02269800Unknown4 期
An Efficacy Study of Benzalkonium Chloride Solution Clearing the Oral Colonized Bacterium in Hospitalized Patients With COPD
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 60
- 主要终点
- Aerobic pathogenic bacterial colonization rate in oral airway
研究概览
简要总结
The purpose of study is to evaluate the efficacy and safety of Benzalkonium Chloride Solution clearing the oral colonized bacterium in hospitalized patients with COPD.
详细描述
This a randomized, double-blind, parallel, single-center, exploratory trial. 60 patients will be randomized to two treatments: benzalkonium chloride solution treatment or normal saline treatment.The purpose of study is to evaluate the efficacy and safety of benzalkonium chloride solution clearing the oral colonized bacterium in hospitalized patients with COPD.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •COPD patients in hospitalized.
- •Aged from18 to 70 years (including 18 and 70).
- •Patients participating in this trial should sign ICFs.
- •Patients with good understanding, could conduct this study with investigators.
排除标准
- •History of mouthwash allergies, allergic rhinitis or dermatitis.
- •Patients with oral ulcers, severe periodontal disease, oral mucosal lesions or oral cancer, patients received special oral clean.
- •Patients with removable denture.
- •Patients with malignant blood diseases.
- •History of using cytotoxic drugs or biological immunosuppressants ( such as TNF-α inhibitors ).
- •Had used clinical study drugs before 28 days enrollment.
- •Had used clinical study drugs before 28 days enrollment.
研究组 & 干预措施
Benzalkonium chloride solution
Experimental
Tid, for 7 days.
干预措施: Benzalkonium chloride solution (Drug)
Normal saline
Active Comparator
Tid, for 7 days.
干预措施: Normal saline (Drug)
结局指标
主要结局
Aerobic pathogenic bacterial colonization rate in oral airway
时间窗: Day 7
次要结局
- The improvement of oral status(Day 7)
- The subjective feeling(Day 7)
- The incidence of hospital acquired respiratory infections(Day 7)
研究者
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