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

NCT01337219 | Unknown Phase 1

• 1 other identifier: RM/NEB-03-10
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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 concentration of tobramycin from 0 to 8h after administration

  from 0 to 8h after administration

Secondary Outcomes (4)

• sputum of tobramycin concentrations

  from 0 to 8 hours after administration

• Safety of Nebcinal® 150mg/3ml administered by Aeroneb® Idehaler pocket®;

  15 days

• Time of nebulization of Nebcinal® 150mg/3ml administered by Aeroneb® Idehaler pocket®

  during nebulization

• Satisfaction of Nebcinal® 150mg/3ml administered by Aeroneb® Idehaler pocket®

  after administration of the drug, in average 20 minutes

Study Arms (2)

Arm A

OTHER

experimental treatment (Nebcinal/Aeroneb Idehaler pocket) - 6day-wash out period - standard treatment (Tobi/Pari LC Plus)

Drug: Tobramycin

Arm B

OTHER

standard treatment (Tobi/Pari LC Plus) - 6day-wash out period - experimental treatment (Nebcinal/Aeroneb Idehaler)

Drug: Tobramycin

Interventions

Tobramycin DRUG

Arm A; Arm B

Eligibility Criteria

• Age: 16 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 tobramycin, hypersensitivity to aminoside

Sponsors & Collaborators

• Erempharma: lead
• University of Lyon: collaborator
• Epidemiologie Pharmacologie Investigation Clinique Information medicale Mere Enfant (EPICIME): collaborator
• Clininfo S.A.: collaborator
• Hospices Civils de Lyon: collaborator

Study Sites (1)

Centre de Ressource et de Compétence Mucoviscidose Pédiatrique Centre de Référence Mucoviscidose

Lyon, 69500, France

RECRUITING

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Tobramycin

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

Intervention Hierarchy (Ancestors)

Nebramycin; Kanamycin; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• behrouz Kassai, Dr

  University of Lyon

  STUDY CHAIR

Central Study Contacts

Behrouz Kassaï

CONTACT

04 27857732

Jean-Paul Salin

CONTACT

0140899260

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 13, 2011
• First Posted: April 18, 2011
• Study Start: April 1, 2011
• Primary Completion: September 1, 2011
• Last Updated: April 18, 2011

Record last verified: 2011-02

Locations

FR (1)