NCT00420836已完成1 期
Crossover Pharmacokinetic Study of Tobramycin Administered for Inhalation by PARI eFlow® Rapid Electronic Nebulizer (no Compressor) vs. PARI LC PLUSTM Jet Nebulizer (With Compressor) in Cystic Fibrosis Subjects
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 20
- 主要终点
- Aerosol delivery characteristics of tobramycin when inhaled using either PARI LC PLUS jet nebulizer or PARI eFlow rapid Electronic Nebulizer evaluated by serum concentrations
研究概览
简要总结
This study assesses the aerosol delivery characteristics (measured by nebulization time, serum and sputum tobramycin pharmacokinetic parameters) and safety of tobramycin administered for inhalation by PARI eFlow rapid electronic nebulizer (no compressor) vs. PARI LC PLUS Jet Nebulizer (with compressor) in subjects with cystic fibrosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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
- •Male and female subjects aged 6 years or over at the time of screening,
- •Chronically colonized with Pseudomonas aeruginosa.
- •Diagnosis of cystic fibrosis (CF)
- •Ability to expectorate sputum samples on command.
- •Ability to tolerate a 1-week washout interval with no inhaled tobramycin or other aminoglycoside treatment.
- •Clinically stable in the opinion of the investigator.
排除标准
- •Inhaled or intravenous aminoglycosides within 7 days before study drug administration.
- •Any investigational drug within 2 weeks before screening.
- •Loop diuretics within 7 days before study drug administration.
- •Current use of inhaled tobramycin delivered by the PARI LC PLUS jet nebulizer without washout period of at least 1 week before entering the study.
- •Women who are, or plan to become, pregnant during the course of the study.
- •Serum creatinine or blood urea (BU) above the upper limit of normal for sex and age, or an abnormal urine analysis
- •Known local or systemic hypersensitivity to aminoglycosides.
- •Other protocol defined inclusion/exclusion criteria may apply.
结局指标
主要结局
Aerosol delivery characteristics of tobramycin when inhaled using either PARI LC PLUS jet nebulizer or PARI eFlow rapid Electronic Nebulizer evaluated by serum concentrations
次要结局
- Potential accumulation of tobramycin in serum measured as the change in tobramycin levels from the first day of treatment to the last day of treatment.
- Pharmacokinetics
- Safety assessed by adverse events, serious adverse events
研究者
相似试验
尚未招募
不适用
Gedrag van nasaal toegediende tobramycine en colistine in het lichaam van patiënten met taaislijmziekteCystic FibrosisNL-OMON28674none10
已完成
1 期
Tobramycin Administered at the Beginning of DialysisRenal DialysisRenal Failure, ChronicNCT03904836Maisonneuve-Rosemont Hospital11
已完成
1 期
Pharmacokinetic and Pharmacoscintigraphic Comparison of TobrAir® 6.0 With TOBI® and TOBI® Podhaler™HealthyNCT02207426Pharmaero ApS12
已完成
不适用
Pharmacokinetics of nasally administered tobramycin and colistin in Cystic FibrosisCystic Fibrosis100386861000401810024970mucoviscidosisNL-OMON38737HagaZiekenhuis10
Unknown
不适用
Efficacy & Tolerability of Tobramycin Podhaler in Bronchiectasis Patients With Chronic Pseudomonas Aeruginosa InfectionBronchiectasis With Chronic Infection With Pseudomonas AeruginosaNCT02102152Rabin Medical Center40