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)

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:
University of Lyon
Epidemiologie Pharmacologie Investigation Clinique Information medicale Mere Enfant (EPICIME)
Clininfo
Hospices Civils de Lyon
Information provided by:
Erempharma
ClinicalTrials.gov Identifier:
NCT01337219
First received: April 13, 2011
Last updated: April 15, 2011
Last verified: February 2011
  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 Phase
Cystic Fibrosis
Drug: Tobramycin
Phase 1
Phase 2

Study Type: Interventional
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.

Resource links provided by NLM:


Further study details as provided by Erempharma:

Primary Outcome Measures:
  • Plasma concentration of tobramycin from 0 to 8h after administration [ Time Frame: from 0 to 8h after administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 36
Study Start Date: April 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm A
experimental treatment (Nebcinal/Aeroneb Idehaler pocket) - 6day-wash out period - standard treatment (Tobi/Pari LC Plus)
Drug: Tobramycin
Arm B
standard treatment (Tobi/Pari LC Plus) - 6day-wash out period - experimental treatment (Nebcinal/Aeroneb Idehaler)
Drug: Tobramycin

  Eligibility

Ages Eligible for Study:   16 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 tobramycin, 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: NCT01337219

Contacts
Contact: Behrouz Kassaï 04 27857732 ext 0033
Contact: Jean-Paul Salin 0140899260 ext 0033

Locations
France
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    gabriel.bellon@chu-lyon.fr   
Principal Investigator: Gabriel Bellon, Pr         
Sponsors and Collaborators
Erempharma
University of Lyon
Epidemiologie Pharmacologie Investigation Clinique Information medicale Mere Enfant (EPICIME)
Clininfo
Hospices Civils de Lyon
Investigators
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 University of Lyon
  More Information

No publications provided

Responsible Party: Erempharma
ClinicalTrials.gov Identifier: NCT01337219     History of Changes
Other Study ID Numbers: RM/NEB-03-10
Study First Received: April 13, 2011
Last Updated: April 15, 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:
Fibrosis
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on September 18, 2014