ACTRN12605000229673招募中3 期
A triple-blind, placebo controlled clinical trial which is designed to determine whether a weekly dose of 1 gram oral azithromycin for one year will reduce acute infective exacerbations in adult Aboriginal Australians adults with chronic obstructive pulmonary disease (COPD).
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 130
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 ot stated（—）
- 性别
- All
入选标准
- •Informed consent- Indigenous Australian. COPD as defined: FEV1<75% predicted and FEV1/FVC<70%, AND <15%improvement in FEV1 following administration of bronchodilators as determined by spirometry before and 10minutes after inhaling 200mcg of salbutamol from a metered dose inhaler, AND chronic cough and sputum production on most days for greater than one year.
排除标准
- •Pregnant women, women intending to become pregnant during the course of the study and lactating women.- People participating in any other study of antibiotics or vaccines.- People already on long term antibiotics- People allergic to the macrolide antibiotics - Evidence of bronchiectasis on chest X ray- People with other serious illnesses, which make them unsuitable for the study, ie. Severe heart or kidney disease.- Inability to perform adequate spirometry- Those who are unlikely to be available for the duration of the trial, for example; those who also live at an outstation or another community.
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