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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Erempharma.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Hopitaux de Lyon
University of Lyon
Information provided by:
Erempharma
ClinicalTrials.gov Identifier:
NCT01288170
First received: February 1, 2011
Last updated: NA
Last verified: February 2011
History: No changes posted
  Purpose

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®


Condition Intervention
Cystic Fibrosis
Drug: Nebcinal Tobi
Drug: Tobi Nebcinal

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics 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®

Resource links provided by NLM:


Further study details as provided by Erempharma:

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

Estimated Enrollment: 12
Study Start Date: February 2010
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Nebcinal Tobi
crossover design
Drug: Nebcinal Tobi
Tobi Nebcinal
crossover design
Drug: Tobi Nebcinal

  Eligibility

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 tobramycine, hypersensitivity to aminoside

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01288170

Contacts
Contact: Behrouz Kassaï 0427857732 ext 0033 behrouz.kassai-koupai@chu-lyon.fr

Locations
France
Centre de ressources et de compétences pour la mucovisidose, enfants Recruiting
Bron, France, 69500
Principal Investigator: Gabriel Bellon, Professor         
Centre de ressources et de compétences pour la mucovisidose, adultes Not yet recruiting
Pierre-Bénite, France, 69495
Sub-Investigator: Isabelle Durieu, Professor         
Sponsors and Collaborators
Erempharma
Hopitaux de Lyon
University of Lyon
  More Information

No publications provided

Responsible Party: Jean Pierre Salin, EREMPHARMA
ClinicalTrials.gov Identifier: NCT01288170     History of Changes
Other Study ID Numbers: RM/NEB-02/09
Study First Received: February 1, 2011
Last Updated: February 1, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Erempharma:
cystic fibrosis, bioequivalence, pharmacokinetic, sputum, plasma

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 22, 2014