NCT00254566已完成3 期
A Phase 3B Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial To Evaluate The Efficacy and Safety Of Azithromycin SR (Microspheres Formulation) Versus Moxifloxacin For The Treatment Of Acute Exacerbation Of Chronic Bronchitis (AECB).
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 398
- 试验地点
- 1
- 主要终点
- Percentage of Clinical Cure (Success) at Test of Cure Visit(Clinical Per Protocol Population)
研究概览
简要总结
This trial is a research drug study to compare the effects of two antibiotics for the treatment of acute exacerbation of chronic bronchitis
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of chronic bronchitis (chronic cough and sputum production on most days for three consecutive months for more than two consecutive years) and clinical evidence of AECB as demonstrated by both the following symptoms:
- •Production of purulent sputum as defined by Gram stained sputum specimen
- •Presence of all of the following:
- •Increased sputum production
- •Increased dyspnea
- •Increased cough
- •At least two exacerbations of AECB in the past 12 months
- •Documented FEV1 less than 80% of predicted
排除标准
- •A chest radiograph consistent with pneumonia
- •Treatment with any systemic antibiotic within the twenty-one days prior to study entry or those with a chance of receiving other systemic antibiotics during study participation
研究组 & 干预措施
1
Experimental
干预措施: Azithromycin SR Placebo (Other)
1
Experimental
干预措施: Azithromycin SR (Drug)
2
Active Comparator
干预措施: Moxifloxacin Placebo (Other)
2
Active Comparator
干预措施: Moxifloxacin (Drug)
结局指标
主要结局
Percentage of Clinical Cure (Success) at Test of Cure Visit(Clinical Per Protocol Population)
时间窗: Test of Cure (TOC) Visit (Day 12-19)
Cure=Signs\&symptoms(S\&S) of infection return to normal baseline level or clin improvement requiring no other antibiotics(AB); Failure=other AB due to S\&S of acute infection persisted/worsened,new clinical S\&S of acute infection,or clinical/radiological evidence of pneumonia developed during treatment; percent = # of cure or failure/total # of sub
次要结局
- Percentage of Clinical Cure (Success) at Test of Cure Visit (Full Analysis Set)(Test of Cure (TOC) Visit (Day 12-19))
- Percentage of Bacteriologic Response at Test of Cure Visit(Test of Cure (TOC) Visit (Day 12-19))
- Change From Baseline in Clinical COPD Questionnaire(CCQ)Symptoms Score(Test of Cure (TOC) Visit (Day 12-19))
- Change From Baseline in Clinical COPD Questionnaire(CCQ)Functional State Score(Test of Cure (TOC) Visit (Day 12-19))
- Percentage of Clinical Cure (Success)at Test of Cure Visit(Clinically Eligible Set)(Test of Cure (TOC) Visit (Day 12-19))
- Time Taken for First Quartile (25%) of Subjects to Have AECB Recurrence(Number of Days)
- Change From Baseline in Clinical COPD Questionnaire(CCQ)Total Score(Test of Cure (TOC) Visit (Day 12-19))
- Change From Baseline in Clinical COPD Questionnaire(CCQ)Mental State Score(Test of Cure (TOC) Visit (Day 12-19))
研究者
研究点 (1)
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