NCT01112410Unknown2 期
A Randomised Double Blind 13 Week Crossover Trial of Hypertonic Saline (6%) Versus Isotonic Saline (0.9%) in Patients With Bronchiectasis.
适应症
试验速览
- 阶段
- 2 期
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- 24 hour sputum volume
研究概览
简要总结
The investigators hypothesise that nebulised hypertonic saline (6%) will increase the volume of sputum expectorated over a 24 hour period compared to nebulised isotonic saline (0.9%) in patients with mild to severe stable bronchiectasis.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non CF Bronchiectasis
- •18-80 years
- •FEV1 less than 90%
- •Chronic sputum production
- •Clinical stable
排除标准
- •Intolerance to HTS
- •Use of HTSaline or antibiotics 14 days prior to study
- •Clinically unstable
结局指标
主要结局
24 hour sputum volume
时间窗: 13 weeks
24 hour volume sputum
次要结局
- Patient Reported Outcome: Leicester Cough Questionnaire:(13 weeks)
- Bronchiectasis Qol Questionnaire(13 weeks)
- Pulmonary Function Testing(13 weeks)
- Rheology(13 weeks)
- Adherence(13 weeks)
- Patient Reported Outcomes RSSQ(13 weeks)
研究者
研究点 (2)
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