NCT03607396Unknown不适用
Study for Evaluating the Real Use of Inhaled Aztreonam Lysine in Patients With Cystic Fibrosis
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 75
- 试验地点
- 3
- 主要终点
- FEV1
研究概览
简要总结
The aim of this observational trial is to evaluate the pulmonary function in cystic fibrosis patients that have been treated with inhaled aztreonam lysine comparing the previous 12 months before the treatment and the forward 12 months after initiating the treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 6 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients above 6 years old that have been treated with Aztreonam Lysine (AZLI) at any time within 12 months before starting the treatment
- •Diagnosis of Cystic Fibrosis confirmed
- •Chronic infection by Pseudomonas aeruginosa
- •Patients can be treated with any inhaled antibiotic before or after AZLI treatment
- •Patients have to have the following FEV1 measures: 12 months before starting AZLI; at AZLI initiation; 12 months after starting AZLI
- •For lung transplant patiens, only data before the transplant will be collected.
排除标准
- •Non applicable
结局指标
主要结局
FEV1
时间窗: 12 months
Forced expiratory volume in one second (FEV1) measured during pulmonary function test.
次要结局
未报告次要终点
研究者
研究点 (3)
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