Pharmacokinetic Bioequivalence Study of Nebcinal® 150mg/3ml Administered by Aeroneb® Idehaler® Versus Tobi® 300mg/5ml Administered by Pari LC Plus®

NCT01288170 | Unknown

• 1 other identifier: RM/NEB-02/09
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

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®

Conditions

Cystic Fibrosis

Keywords

cystic fibrosis, bioequivalence, pharmacokinetic, sputum, plasma

Outcome Measures

Primary Outcomes (1)

• plasma Area under the curve from 0 to 8 hours of tobramycine after administration of the drug

Study Arms (2)

Nebcinal Tobi

OTHER

crossover design

Drug: Nebcinal Tobi

Tobi Nebcinal

OTHER

crossover design

Drug: Tobi Nebcinal

Interventions

Nebcinal Tobi DRUG

Nebcinal Tobi

Tobi Nebcinal DRUG

Tobi Nebcinal

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• \- 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 tobramycine, hypersensitivity to aminoside

Sponsors & Collaborators

• Erempharma: lead
• Hospices Civils de Lyon: collaborator
• University of Lyon: collaborator

Study Sites (2)

Centre de ressources et de compétences pour la mucovisidose, enfants

Bron, 69500, France

RECRUITING

Centre de ressources et de compétences pour la mucovisidose, adultes

Pierre-Bénite, 69495, France

NOT YET RECRUITING

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Central Study Contacts

Behrouz Kassaï

CONTACT

0427857732; behrouz.kassai-koupai@chu-lyon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 1, 2011
• First Posted: February 2, 2011
• Study Start: February 1, 2010
• Primary Completion: July 1, 2010
• Last Updated: February 2, 2011

Record last verified: 2011-02

Locations

FR (2)