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Tobramycin Administered by eF...

Tobramycin Administered by eFlow Rapid Nebulizer: Pharmacokinetic Study

NCT ID: NCT00420836

Last Updated: 2007-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Cystic Fibrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Tobramycin

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers