NCT00170222已完成4 期
The Value of Antibiotic Treatment of Exacerbations of Hospitalised COPD Patients
Medical Center Alkmaar2 个研究点 分布在 1 个国家目标入组 258 人开始时间: 2002年7月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 258
- 试验地点
- 2
- 主要终点
- Clinical efficacy at the end of treatment
研究概览
简要总结
The role of antibiotic therapy in patients with COPD remains controversial. While the outcome of several clinical trials is in favour of antibiotics, the quality of these studies in insufficient. In this study the efficacy of doxycycline is compared to placebo. All concommitant treatment (steroids, bronchodilator therapy, physiotherapy) is standardized.
The investigators hypothesize that patients with an acute exacerbations will have a better outcome when treated with antibiotics.
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
- Double
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute exacerbation of COPD type I or II according to GOLD
- •Ability to perform lung function tests
- •Ability to take oral medication
排除标准
- •Pregnant or lactating women, or women of childbearing age not using an acceptable method of contraception.
- •Pretreatment ( > 24 hours) with an antibiotic for the present exacerbation.
- •Pretreatment with corticosteroids (>30 mg for more than 4 days) for the present exacerbation.
- •Progression or new radiographic abnormalities on the chest X-ray.
- •Severe exacerbation that required mechanical ventilation.
- •History of bronchiectasis
- •Recent or unresolved lung malignancy.
- •Other disease likely to require antibiotic therapy.
- •Significant gastrointestinal or other conditions that may affect study drug absorption.
- •Class III or IV congestive heart failure or stroke.
- •Immunodeficiency disorders such as AIDS, humoral immune defect, ciliary dysfunction etc. and the use of immunosuppressive drugs (>30 mg prednisolone maintenance dose or equivalent for more than 4 weeks).
- •Cystic fibrosis
- •Tuberculosis.
- •Impaired renal function (creatinine clearance < 20 ml/min).
结局指标
主要结局
Clinical efficacy at the end of treatment
次要结局
- Treatment failure at follow up
- Number of exacerbation
研究者
研究点 (2)
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