Clinical trial NCT01337219: 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
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Cystic Fibrosis
Keywords: cystic fibrosis
bioequivalence
pharmacokinetic
sputum
plasma
Lead sponsor: Erempharma
Sponsor class: INDUSTRY
Collaborators: name: University of Lyon
name: Epidemiologie Pharmacologie Investigation Clinique Information medicale Mere Enfant (EPICIME)
name: Clininfo S.A.
name: Hospices Civils de Lyon
First posted: 2011-04-18
Enrollment: 36
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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®


Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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

Primary outcomes:
measure: Plasma concentration of tobramycin from 0 to 8h after administration
timeFrame: from 0 to 8h after administration
Secondary outcomes:
measure: sputum of tobramycin concentrations
timeFrame: from 0 to 8 hours after administration
measure: Safety of Nebcinal® 150mg/3ml administered by Aeroneb® Idehaler pocket®;
timeFrame: 15 days
measure: Time of nebulization of Nebcinal® 150mg/3ml administered by Aeroneb® Idehaler pocket®
timeFrame: during nebulization
measure: Satisfaction of Nebcinal® 150mg/3ml administered by Aeroneb® Idehaler pocket®
timeFrame: after administration of the drug, in average 20 minutes
Other outcomes:
Locations:
city: Lyon
country: France
facility: Centre de Ressource et de Compétence Mucoviscidose Pédiatrique Centre de Référence Mucoviscidose
Study officials:
affiliation: Centre de Resources et de competences pour la mucovisidose
name: Gabriel Bellon
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre de Resources et de competences pour la mucovisidose Hôpital Lyon Sud
name: Isabelle Durieu, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Lyon
name: behrouz Kassai, Dr
role: STUDY_CHAIR
References: