A Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of Oral Azithromycin (500 Mg OD) as a Supplement to Standard Care for Adult Patients With Acute Exacerbations of Asthma
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 199
- 试验地点
- 14
- 主要终点
- Diary card summary symptom score
研究概览
简要总结
Acute attacks (exacerbations) of asthma are common and cause a great deal of suffering in asthmatic patients. Current treatments for asthma attacks are not completely effective and new and better treatments are needed. Viruses often cause asthma attacks and bacterial lung infections have also been associated with asthma attacks. However, the role for bacteria is uncertain. Current asthma guidelines for doctors treating asthma exacerbations do not recommend the routine use of antibiotics. The investigators would like to investigate whether or not azithromycin, which is a safe and well tolerated antibiotic (an antibacterial) that has been used for many years in the treatment of respiratory disease, might be of benefit in asthma attacks. As there is some evidence that azithromycin has anti-viral properties this may add to its benefits (antibiotics don't usually affect viruses). By looking at the effect of azithromycin on asthma attacks this will help us to show whether or not azithromycin should be recommended during an acute asthma attack in addition to the usual care that is provided to these patients as it may help them recover quicker from the exacerbation. The investigators will also be able to look at why azithromycin may be effective - if it is having an anti-bacterial and/or anti-viral effect.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(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
Azithromycin (Zithromax)
500 mg of azithromycin (2×250mg capsules)
干预措施: Zithromax (Drug)
Placebo
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Diary card summary symptom score
时间窗: 10 days after randomisation
Symptoms include wheezing, breathlessness and coughing assessed at 10 days after randomisation.
次要结局
- Time to 50% reduction in symptom score(From Visit 1 (day 1) to Visit 4 (day 42))
- Quality of life assessed by acute asthma QolQ (Juniper)(5 & 10 days post randomisation)
- Pulmonary Function tests(5 & 10 days post randomisation)
