NCT00538148已完成4 期
A Multicenter, Multinational, Randomized, DB Controlled Study of the Efficacy & Safety of Oral Telithromycin 800 mg Once QD for 5 Days vs Azithromycin in the Treatment of Acute Exacerbation of Chronic Bronchitis in Adult Outpatients With COPD.
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 668
- 主要终点
- Principal efficacy criterion: clinical outcome - Main secondary efficacy criteria: - Bacteriological response at TOC visit; - Time to relapse up to 6 months after inclusion.
研究概览
简要总结
Non-inferiority efficacy of telithromycin versus azithromycin
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 (Participant, Investigator)
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
- •Adult outpatients, either sex, aged 45 years or older.
- •Patients with a documented history of chronic bronchitis with a basal FEV1 <70% and >35% made in the previous 12 months and who had had at least one or more AEBC in the previous year and with FEV1/FVC <70% (lung function tests made in the previous 12 months).
- •Patients with a clinical diagnosis of acute exacerbation of chronic bronchitis presumably due to bacterial infection based on all of the following signs and symptoms of AECB: increased sputum purulence, and at least 1 of the 2 following signs and symptoms (increased dyspnea, increased sputum volume).
- •Patients with negative chest radiography (posterior/anterior and lateral views) to rule out a pneumonia within 48 hours before initiation of study medication or at the latest 24 hours after initiation of study medication (it was necessary to not include patients with pneumonia associated with AECB).
- •Patients with sputum specimens collected at inclusion for gram stain and bacteriological culture.
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
排除标准
- 未提供
结局指标
主要结局
Principal efficacy criterion: clinical outcome - Main secondary efficacy criteria: - Bacteriological response at TOC visit; - Time to relapse up to 6 months after inclusion.
时间窗: At TOC visit (Day 17-Day 21).
次要结局
未报告次要终点
研究者
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