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临床试验/NCT00147667
NCT00147667Unknown2 期

Randomised Double Blind Placebo Controlled Trial of Effects of Long Term Low Dose Oral Erythromycin Therapy in Patients With Chronic Obstructive Pulmonary Disease

Royal Free and University College Medical School2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2004年4月1日最近更新:
适应症
相关药物

试验速览

阶段
2 期
发起方
入组人数
120
试验地点
2
主要终点
Exacerbation Frequency

研究概览

简要总结

The purpose of this study is to determine whether long term treatment with oral erythromycin is effective in the treatment of subjects with Chronic Obstructive Pulmonary Disease (COPD) by reducing the number of exacerbations and the degree of airway inflammation.

详细描述

COPD is characterised by persisting airway inflammation which leads to a progressive and irreversible deterioration in lung function with the eventual development of respiratory symptoms which may become disabling. Periodic episodes of worsening symptoms or exacerbations are a major cause of additional morbidity, mortality and health care utilization. Currently available therapies have limited efficacy in reducing airway inflammation or preventing exacerbations.

Macrolides such as erythromycin have been shown to have potent anti-inflammatory effects in in vitro experiments and in other lung conditions such as cystic fibrosis and bronchiectasis as well as in open label studies in COPD. We hypothesised that long term therapy with oral erythromycin would reduce airway inflammation and reduce the frequency of exacerbations in patients with COPD. If these properties are demonstrated this therapy can have potentially important benefits if effective in this condition.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Double

入排标准

年龄范围
40 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical Diagnosis of COPD
  • Clinically stable for 6 weeks
  • Able to Swallow Tablets

排除标准

  • Clinically significant respiratory disease other than COPD
  • Women of child bearing age
  • Patients receiving existing Medication which may interact adversely with trial drug
  • History of clinically significant liver disease

结局指标

主要结局

Exacerbation Frequency

Airway Inflammation

次要结局

  • Symptoms
  • Exacerbation Recovery Time
  • Lung Function
  • Health Status

研究者

发起方
Royal Free and University College Medical School
申办方类型
Other

研究点 (2)

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