NCT03736629终止2 期
The AZITRAMBA Trial: Azithromycin Treatment for the Airway Microbiome in Asthma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Asthma Control Test (ACT) Score Change From Baseline Over 8 Weeks
研究概览
简要总结
The purpose of this study to determine whether the bacteria inside the lungs of people with asthma can be modified (changed) if they are given an antibiotic and if this change is associated with an improvement in asthma symptoms.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo
Placebo Comparator
8 weeks of placebo capsule once daily by mouth
干预措施: Placebo (Drug)
Azithromycin
Active Comparator
8 weeks of Azithromycin (250 mg) capsule once daily by mouth
干预措施: Azithromycin (Drug)
结局指标
主要结局
Asthma Control Test (ACT) Score Change From Baseline Over 8 Weeks
时间窗: Baseline and 8 weeks
Score ranging from 0 to 40 indicating the degree of asthma symptoms. Lower score indicating worse asthma symptoms.
次要结局
- Forced Expiratory Volume (FEV1) Change From Baseline Over 8 Weeks(8 weeks)
- Sputum Eosinophils Change From Baseline Over 8 Weeks(Baseline and 8 weeks)
- Sputum Neutrophils Change From Baseline Over 8 Weeks(Baseline and 8 weeks)
- Number of Participants With Diary Event or Serious Asthma Exacerbation Over 8 Weeks(8 weeks)
- Microbiome Shannon Alpha-diversity Score Change From Baseline to 8 Weeks(8 weeks)
- Microbiome Beta-diversity Score Change From Baseline to 8 Weeks(8 weeks)
- Microbiome Change in Relative Proportion of Top 10 Genera From Baseline to 8 Weeks(8 weeks)
研究者
研究点 (2)
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