Cystic Fibrosis Clinical Trial
Official title:
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.
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®
n/a
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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