NCT01460836已完成不适用
Indirect Comparison of Tobramycin Solution for Inhalation Versus Aztreonam Lysine for Inhalation in the Treatment of Cystic Fibrosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 主要终点
- Mean relative change in Forced Expiratory Volume in 1 second (FEV1) from baseline
研究概览
简要总结
Matching-adjusted indirect comparison of tobramycin solution (TIS) versus aztreonam lysine (AZLI) using TIS patient level clinical trial data and AZLI aggregated clinical trial data from published literature.
研究设计
- 研究类型
- Observational
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 6 years of age with a documented Cystic fibrosis (CF) diagnosis,
- •moderate-to severe lung disease,
- •the ability to perform reproducible pulmonary function tests,
- •Pseudomonas aeruginosa (PA) airway infection.
排除标准
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Tobramycin Solution
干预措施: Tobramycin solution for inhalation (Drug)
Aztreonam lysine
干预措施: Aztreonam lysine for inhalation (Drug)
结局指标
主要结局
Mean relative change in Forced Expiratory Volume in 1 second (FEV1) from baseline
时间窗: Baseline, Weeks 2, 4 and 6
次要结局
- Mean change in the density of Pseudomonas aeruginosa (PA) from baseline(Baseline, Weeks 2, 4 and 6)
研究者
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