NCT00749866已完成4 期
Can Long Term Nebulised Gentamicin Reduce The Bacterial Burden, Break the Vicious Cycle of Inflammation and Improve Quality of Life in Patients With Bronchiectasis
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
- 60
- 试验地点
- 1
- 主要终点
- Reduction in bacterial load
研究概览
简要总结
The hypothesis of this randomized placebo controlled trial is that targeted nebulized gentamicin to the airways will reduce bacterial burden and limit neutrophil airways inflammation. If given long term this will improve symptoms, pulmonary physiology, exercise capacity and health related quality of life with a reduction in exacerbation frequency and health care utilization.
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
- Single (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
- •Bronchiectasis confirmed by HRCT of the chest
- •Clinically stable (not requiring antibiotics for at least 4 weeks preceding the study start date)
- •Aged 18-70
- •Chronic sputum production > 5 mls for the majority of days in 3 months before enrolment
- •Chronically colonized (on at least 2 occasions in the preceding 12 months) whilst clinically stable
- •At least two exacerbations in the past year
- •Patients able to tolerate a nebulized gentamicin challenge
- •FEV1 > 30% predicted
- •Smoking < 20 pack year history and ex-smokers >1 year.
排除标准
- •Cystic fibrosis
- •Emphysema on HRCT chest
- •Thoracic surgery within the past 1 year
- •Allergic bronchopulmonary aspergillosis
- •Poorly controlled asthma ( > 20% diurnal variation in peak expiratory flows despite treatment)
- •Unstable angina or uncontrolled congestive cardiac failure
- •Active malignancy
- •Pregnancy or breast feeding
- •Creatinine clearance < 30 mls/minute
- •Vestibular instability
- •Previous documented intolerance to aminoglycosides
研究组 & 干预措施
1
Active Comparator
Nebulised Gentamicin
干预措施: Gentamicin (Drug)
2
Placebo Comparator
Nebulised 0.9% Saline
干预措施: Saline (Drug)
结局指标
主要结局
Reduction in bacterial load
时间窗: 1 year
次要结局
- Health Related Quality of Life(1 Year)
- airways and systemic inflammation(1 year)
- Spirometry and exercise capacity(1 year)
- Exacerbation frequency(1 year)
- Long term safety with nebulised Gentamicin(1 Year)
研究者
研究点 (1)
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Can long term nebulised gentamicin reduce the bacterial burden, break the vicious cycle of inflammation and improve quality of life in patients with bronchiectasis? - Impact of nebulised gentamicin in patients with bronchiectasisBronchiectasis is respiratory disease with damaged airways. Such patients have frequent bacterial chest infections. The aim of our study is to assess whether nebulised gentamicin 80mg twice daily will reduce the bacteria in the airways and make patients feel better.EUCTR2006-000338-10-GBHS Lothian Health Board
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