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临床试验/NCT01444469
NCT01444469已完成4 期

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

Imperial College London14 个研究点 分布在 1 个国家目标入组 199 人开始时间: 2011年9月最近更新:
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
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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Azithromycin (Zithromax)

Experimental

500 mg of azithromycin (2×250mg capsules)

干预措施: Zithromax (Drug)

Placebo

Placebo Comparator

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (14)

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