Pharmacokinetic Bioequivalence Study of Nebcinal® 150mg/3ml Administered by Aeroneb® Idehaler® Versus Tobi® 300mg/5ml Administered by Pari LC Plus® /Pulmoaide® in Patients With Cystic Fibrosis.
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Plasma concentration of tobramycin from 0 to 8h after administration
研究概览
简要总结
Cystic fibrosis (CF) is a genetic disease characterized by mutations in CFTR (Cystic Fibrosis Transmembrane conductance Regulator) gene. Mortality and morbidity are mostly related to the respiratory affection which appears early in neonates.
The constant improvement in symptomatic treatments and care strategies allowed CF patients' life expectancy to be increased over the last decades.
Vital prognostic is related to bronchopulmonary infections. 39% of CF patients under 18 years old and 70% of adult CF patients are chronically infected by Pseudomonas aeruginosa.
Elevated concentrations of tobramycin in broncho secretions, about 1000 times the MIC, is obtained by inhaled administration of tobramycin and is active against in-vitro resistant Pseudomonas aeruginosa.
Study hypotheses :
Regarding literature data and in-vitro studies, the administration of Nebcinal® 150mg/3ml administered twice a day by Aeroneb® Idehaler® pocket® would deliver the same quantity of antibiotic in lung and plasma as Tobi® 300mg/5ml administered twice a day by Pari® LC Plus® in children and adult patients with CF.
Primary objective :
To compare plasma concentrations after inhalation of Nebcinal® 150mg/3ml administered by Aeroneb® Idehaler pocket® and Tobi® 300 mg/5ml administered by Pari LC Plus®
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults and children aged 6 years old and more
- •Male or female
- •Patients with cystic fibrosis (positive sudoral test, Cl > 60 mmol/L)
- •Followed in a CRCM (CF care centre)
- •FEV1 ≥40%
- •Informed consent collected from adults or parents or legal guardians and children.
- •Affiliation to the National Health Insurance program (Sécurité sociale).
排除标准
- •renal insufficiency defined by a creatinine clearance level superior to 2 mg/dl
- •recent pneumothorax, emphysema, punction or recent pleural biopsy, recent haemoptysis superior to 60 ml within 30 days prior to randomization
- •Acute pulmonary exacerbation pathology, according to conference of consensus (2002), evaluated by :
- •Cough increase
- •Sputum increase
- •Decrease in tolerance to effort
- •Loss of weight, lack of appetite
- •Deterioration of respiratory function
- •Medical history of intolerance, toxicity or allergy to tobramycin, hypersensitivity to aminoside
研究组 & 干预措施
Arm A
experimental treatment (Nebcinal/Aeroneb Idehaler pocket) - 6day-wash out period - standard treatment (Tobi/Pari LC Plus)
干预措施: Tobramycin (Drug)
Arm B
standard treatment (Tobi/Pari LC Plus) - 6day-wash out period - experimental treatment (Nebcinal/Aeroneb Idehaler)
干预措施: Tobramycin (Drug)
结局指标
主要结局
Plasma concentration of tobramycin from 0 to 8h after administration
时间窗: from 0 to 8h after administration
次要结局
- sputum of tobramycin concentrations(from 0 to 8 hours after administration)
- Safety of Nebcinal® 150mg/3ml administered by Aeroneb® Idehaler pocket®;(15 days)
- Time of nebulization of Nebcinal® 150mg/3ml administered by Aeroneb® Idehaler pocket®(during nebulization)
- Satisfaction of Nebcinal® 150mg/3ml administered by Aeroneb® Idehaler pocket®(after administration of the drug, in average 20 minutes)