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

Primary Purpose

Cystic Fibrosis

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Nebcinal Tobi

Tobi Nebcinal

About this trial

This is an interventional treatment trial for Cystic Fibrosis focused on measuring cystic fibrosis, bioequivalence, pharmacokinetic, sputum, plasma

Eligibility Criteria

6 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Centre de ressources et de compétences pour la mucovisidose, enfantsRecruiting
Centre de ressources et de compétences pour la mucovisidose, adultes

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Nebcinal Tobi

Tobi Nebcinal

Arm Description

crossover design

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01288170

First Posted

February 1, 2011

Last Updated

February 1, 2011

Sponsor

Erempharma

Collaborators

Hospices Civils de Lyon, University of Lyon

1. Study Identification

Unique Protocol Identification Number

NCT01288170

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2011

Overall Recruitment Status

Unknown status

Study Start Date

February 2010 (undefined)

Primary Completion Date

July 2010 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Erempharma

Collaborators

Hospices Civils de Lyon, University of Lyon

4. Oversight

Data Monitoring Committee

5. Study Description

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®

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cystic Fibrosis

Keywords

cystic fibrosis, bioequivalence, pharmacokinetic, sputum, plasma

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Nebcinal Tobi

Arm Type

Other

Arm Description

crossover design

Arm Title

Tobi Nebcinal

Arm Type

Other

Arm Description

crossover design

Intervention Type

Drug

Intervention Name(s)

Nebcinal Tobi

Intervention Type

Drug

Intervention Name(s)

Tobi Nebcinal

Primary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Accepts Healthy Volunteers

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 tobramycine, hypersensitivity to aminoside

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Behrouz Kassaï

Phone

0427857732

Ext

0033

behrouz.kassai-koupai@chu-lyon.fr

Facility Information:

Facility Name

Centre de ressources et de compétences pour la mucovisidose, enfants

City

Bron

ZIP/Postal Code

69500

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gabriel Bellon, Professor

Facility Name

Centre de ressources et de compétences pour la mucovisidose, adultes

City

Pierre-Bénite

ZIP/Postal Code

69495

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Isabelle Durieu, Professor

12. IPD Sharing Statement

Learn more about this trial

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

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