ISRCTN43262969已完成不适用
Randomised, double-blind, multi-centre, placebo-controlled study to evaluate the efficacy of 6-day additional oral moxifloxacin administration 400 mg once a day (qd) after common antibiotic treatment on acute bacterial exacerbation of chronic obstructive pulmonary disease patients
West China Hospital, Sichuan University (China)0 个研究点目标入组 80 人开始时间: 2009年3月19日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Both males and females, 45-80 years old
- •2. History of COPD (Global Initiative for chronic Obstructive Lung Disease [GOLD] 2006 criteria)
- •3. Moderate to severe COPD (GOLD 2006 criteria)
- •4. Have at least one acute exacerbation episodes in the proceeding year
- •5. Clinical evidence of acute bacteria exacerbations of COPD. Patient must meet criterion 5.1 below plus one of the other four criteria to be eligible:
- •5.1. Production of purulent sputum as defined by gramistained sputum specimen
- •5.2. Increased dyspnoea
- •5.3. Increased sputum production
- •5.4. Fever
- •5.5. Increased white blood cells (WBC) or neutrophilic granulocyte portion
排除标准
- •1. Extremely severe acute exacerbation of chronic obstructive pulmonary disease (AECOPD)
- •2. Comply with pulmonary encephalopathy
- •3. Heart failure,acute cornary artery syndrome
- •4. Gastrointestimal (GI) bleeding
- •5. Need for mechanical ventilation
- •6. History of hypersensitivity to fluoroquinolones
- •7. Creatinine (Cr) >=1 x upper limit of normal (ULN), blood urea nitrogen (BUN) >=1 x ULN, aspartate aminotransferase (AST), alanine aminotransferase (ALT) >= 5 x ULN or total bilirubin >=3 x ULN at screening
- •8. Other chronic respiratory disease that lead to decline in pulmonary function, such as pneumonia, cancer, asthma, bronchiectasis, diffused lung interstitial fibrosis
- •9. Infection that is not because of pulmonary or bronchial tree
- •10. Use of systemic glucocorticoid (prednisolone >10 mg/d or other corticoid equal to this) within 30 days
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