NCT01715493已完成4 期
Pharmacological Effect of Lysozyme for Chronic Obstructive Pulmonary Disease and Asthma With Sputum Symptom: a Randomised Placebo-controlled Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 48
- 主要终点
- Change of several inflammatory or biochemical marker concentration in inducted sputum
研究概览
简要总结
The aim of this study was to assess the effectiveness for small airway inflammation of 4 weeks lysozyme administration in Chronic Obstructive Pulmonary Disease (COPD) and/or asthma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Lysozyme 90 mg
Experimental
干预措施: lysozyme 90 mg (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change of several inflammatory or biochemical marker concentration in inducted sputum
时间窗: 8 weeks (2 periods each lasting 4 weeks)
Peripheral airway resistance and reactance measured by Impulse oscillometry system, and NO concentration.
时间窗: 8 weeks (2 periods each lasting 4 weeks)
次要结局
- Monthly reduction in forced expiratory volume in 1 Second (FEV1)(8 weeks (2 periods each lasting 4 weeks))
- Quality of life assessed by CAT (COPD Assessment Test) and ACT (Asthma Control Test)(8 weeks (2 periods each lasting 4 weeks))
研究者
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未知
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Pharmacological Effect of Lysozyme for Chronic Obstructive Pulmonary Disease and Asthma With Sputum SymptomChronic Obstructive Pulmonary Disease (COPD) and AsthmaJPRN-jRCT1080222009Eisai Co., Ltd.48
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