Pharmacokinetic Bioequivalence Study of Nebcinal® 150mg/3ml Administered by Aeroneb® Idehaler® Versus Tobi® 300mg/5ml Administered by Pari LC Plus® /Pulmoaid® in Patients With Cystic Fibrosis (RM/NEB-03-10)
Recruitment status was Recruiting
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®
|Study Design:||Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|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.|
- Plasma concentration of tobramycin from 0 to 8h after administration [ Time Frame: from 0 to 8h after administration ] [ Designated as safety issue: No ]
- sputum of tobramycin concentrations [ Time Frame: from 0 to 8 hours after administration ] [ Designated as safety issue: No ]
- Safety of Nebcinal® 150mg/3ml administered by Aeroneb® Idehaler pocket®; [ Time Frame: 15 days ] [ Designated as safety issue: Yes ]
- Time of nebulization of Nebcinal® 150mg/3ml administered by Aeroneb® Idehaler pocket® [ Time Frame: during nebulization ] [ Designated as safety issue: No ]
- Satisfaction of Nebcinal® 150mg/3ml administered by Aeroneb® Idehaler pocket® [ Time Frame: after administration of the drug, in average 20 minutes ] [ Designated as safety issue: No ]
|Study Start Date:||April 2011|
|Estimated Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
experimental treatment (Nebcinal/Aeroneb Idehaler pocket) - 6day-wash out period - standard treatment (Tobi/Pari LC Plus)
standard treatment (Tobi/Pari LC Plus) - 6day-wash out period - experimental treatment (Nebcinal/Aeroneb Idehaler)
|Contact: Behrouz Kassaï||04 27857732 ext 0033|
|Contact: Jean-Paul Salin||0140899260 ext 0033|
|Centre de Ressource et de Compétence Mucoviscidose Pédiatrique Centre de Référence Mucoviscidose||Recruiting|
|Lyon, France, 69500|
|Contact: Gabriel Bellon, Pr 04 27 85 59 82 ext 0033 firstname.lastname@example.org|
|Principal Investigator: Gabriel Bellon, Pr|
|Principal Investigator:||Gabriel Bellon||Centre de Resources et de competences pour la mucovisidose|
|Principal Investigator:||Isabelle Durieu, Pr||Centre de Resources et de competences pour la mucovisidose Hôpital Lyon Sud|
|Study Chair:||behrouz Kassai, Dr||Clinical Investigation Center of Lyon|