Which Apparatus for Inhaled Pentamidine? A Comparison of Drug Delivery to the Lung Between Two Nebulizers: The Respirgard II and the Isoneb.
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Amikacine urinary dosage
研究概览
简要总结
The reference nebulizer used for pentamidine nebulization is currently the Respirgard II ®, disposable pneumatic nebulizer. Other nebulizers are on the market and appear to have comparable properties and better availability to the hospital. Several studies remark that all nebulizers with comparable properties could be used for the nebulization.The aim of our work will be to evaluate and compare the pulmonary deposition between the reference nebulizer Respirgard II ®, and one of these nebulizers available on the market, the Isoneb ®. We will measure and compare these data's for each of the nebulizers via nebulization Amikacine and urinary dosage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Be in good health
排除标准
- •Known Tachycardia
- •Renal Dysfunction
- •Respiratory Diseases and history
研究组 & 干预措施
Isoneb
Determination of pulmonary deposition
干预措施: 500mg Amikacine (Amukin®) diluted in 4mL NaCl (0,9%) (Drug)
Respirgard II
Determination of pulmonary deposition
干预措施: 500mg Amikacine (Amukin®) diluted in 4mL NaCl (0,9%) (Drug)
Respirgard II
Determination of pulmonary deposition
干预措施: Respirgard II (Device)
Isoneb
Determination of pulmonary deposition
干预措施: Isoneb® (Device)
结局指标
主要结局
Amikacine urinary dosage
时间窗: 24 hours
次要结局
未报告次要终点
研究者
G.Reychler
Doctor in Physiotherapy
Cliniques universitaires Saint-Luc- Université Catholique de Louvain