NCT01303068已完成不适用
Detection of Pseudomonas. Aeruginosa in the Airways of Patients With Cystic Fibrosis Using of Aerosolized 13C-urea
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- The Primary Objective is to Assess the Safety of 13C Urea Administered by Inhalation.
研究概览
简要总结
The purpose of this study is to determine if inhaled urea can be used to detect the presence of Pseudomonas Aeruginosa in the lungs
详细描述
Dose Escalation study
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with CF aged 18 years and above colonized with P. aeruginosa
- •Normal subjects ages 18 and above without CF or p. aeruginosa
排除标准
- •for patients and volunteers will include the presence of asthma, allergic rhinitis, pregnancy, a history of gastric or duodenal ulcer, smoking, and a baseline FEV1 less than 60% of predicted normal value and a pulmonary exacerbation within the last 2 weeks as defined by use of systemic antibiotic
结局指标
主要结局
The Primary Objective is to Assess the Safety of 13C Urea Administered by Inhalation.
时间窗: 6 hours
The primary endpoint is the safety of inhaled 13C urea assessed by adverse events including pulmonary findings and changes from baseline in physical examination findings, pulse oximetry results, pulmonary function test results, and vital signs.
次要结局
- The Secondary Objective is to Assess the Kinetics of 13C Carbon Dioxide Production by Measuring the Isotopic Ratio of 13C to 12C in Exhaled Carbon Dioxide.(5 minutes post inhalation)
研究者
Hengameh Raissy, Pharm.D.
Research Associate Professor, Pediatrics
University of New Mexico
研究点 (2)
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