Tobramycin Administered by eFlow Rapid Nebulizer: Pharmacokinetic Study

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00420836

Enrollment

Registered

2007-01-11

Start date

2006-04-30

Completion date

Unknown

Last updated

2007-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis

Keywords

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

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.

Interventions

DRUGTobramycin

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Years to No maximum

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/

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Pharmacokinetics	—
Safety assessed by adverse events, serious adverse events	—
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.	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026