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