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Tobramycin Administered by eFlow Rapid Nebulizer: Pharmacokinetic Study

Primary Purpose

Cystic Fibrosis

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

Tobramycin

About this trial

This is an interventional treatment trial for Cystic Fibrosis focused on measuring Cystic fibrosis, tobramycin, PARI eFlow, PARI LC Plus, nebulizer, pharmacokinetic

Eligibility Criteria

6 Years - undefined (Child, Adult, Older Adult)All Sexes

Inclusion Criteria:

Male and female subjects aged 6 years or over at the time of screening,
Chronically colonized with Pseudomonas aeruginosa.
Diagnosis of cystic fibrosis (CF)
Ability to expectorate sputum samples on command.
Ability to tolerate a 1-week washout interval with no inhaled tobramycin or other aminoglycoside treatment.
Clinically stable in the opinion of the investigator.

Exclusion Criteria:

Inhaled or intravenous aminoglycosides within 7 days before study drug administration.
Any investigational drug within 2 weeks before screening.
Loop diuretics within 7 days before study drug administration.
Current use of inhaled tobramycin delivered by the PARI LC PLUS jet nebulizer without washout period of at least 1 week before entering the study.
Women who are, or plan to become, pregnant during the course of the study.
Serum creatinine or blood urea (BU) above the upper limit of normal for sex and age, or an abnormal urine analysis
Known local or systemic hypersensitivity to aminoglycosides.

Other protocol defined inclusion/exclusion criteria may apply.

Sites / Locations

Outcomes

Primary Outcome Measures

Aerosol delivery characteristics of tobramycin when inhaled using either PARI LC PLUS jet nebulizer or PARI eFlow rapid Electronic Nebulizer evaluated by serum concentrations

Secondary Outcome Measures

Potential accumulation of tobramycin in serum measured as the change in tobramycin levels from the first day of treatment to the last day of treatment.

Pharmacokinetics

Safety assessed by adverse events, serious adverse events

Full Information

NCT ID

NCT00420836

First Posted

January 10, 2007

Last Updated

January 10, 2007

Sponsor

Novartis

1. Study Identification

Unique Protocol Identification Number

NCT00420836

Brief Title

Tobramycin Administered by eFlow Rapid Nebulizer: Pharmacokinetic Study

Official Title

Crossover Pharmacokinetic Study of Tobramycin Administered for Inhalation by PARI eFlow® Rapid Electronic Nebulizer (no Compressor) vs. PARI LC PLUSTM Jet Nebulizer (With Compressor) in Cystic Fibrosis Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

January 2007

Overall Recruitment Status

Completed

Study Start Date

April 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Novartis

4. Oversight

5. Study Description

Brief Summary

This study assesses the aerosol delivery characteristics (measured by nebulization time, serum and sputum tobramycin pharmacokinetic parameters) and safety of tobramycin administered for inhalation by PARI eFlow rapid electronic nebulizer (no compressor) vs. PARI LC PLUS Jet Nebulizer (with compressor) in subjects with cystic fibrosis.

6. Conditions and Keywords

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

Cystic Fibrosis

Keywords

Cystic fibrosis, tobramycin, PARI eFlow, PARI LC Plus, nebulizer, pharmacokinetic

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Tobramycin

Primary Outcome Measure Information:

Title

Aerosol delivery characteristics of tobramycin when inhaled using either PARI LC PLUS jet nebulizer or PARI eFlow rapid Electronic Nebulizer evaluated by serum concentrations

Secondary Outcome Measure Information:

Title

Potential accumulation of tobramycin in serum measured as the change in tobramycin levels from the first day of treatment to the last day of treatment.

Title

Pharmacokinetics

Title

Safety assessed by adverse events, serious adverse events

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Eligibility Criteria

Inclusion Criteria: Male and female subjects aged 6 years or over at the time of screening, Chronically colonized with Pseudomonas aeruginosa. Diagnosis of cystic fibrosis (CF) Ability to expectorate sputum samples on command. Ability to tolerate a 1-week washout interval with no inhaled tobramycin or other aminoglycoside treatment. Clinically stable in the opinion of the investigator. Exclusion Criteria: Inhaled or intravenous aminoglycosides within 7 days before study drug administration. Any investigational drug within 2 weeks before screening. Loop diuretics within 7 days before study drug administration. Current use of inhaled tobramycin delivered by the PARI LC PLUS jet nebulizer without washout period of at least 1 week before entering the study. Women who are, or plan to become, pregnant during the course of the study. Serum creatinine or blood urea (BU) above the upper limit of normal for sex and age, or an abnormal urine analysis Known local or systemic hypersensitivity to aminoglycosides. Other protocol defined inclusion/exclusion criteria may apply.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Basel

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

Tobramycin Administered by eFlow Rapid Nebulizer: Pharmacokinetic Study

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