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

Novartis0 sites20 target enrollmentApril 2006

ConditionsCystic Fibrosis

DrugsTobramycin

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Cystic Fibrosis
Sponsor: Novartis
Enrollment: 20
Primary Endpoint: Aerosol delivery characteristics of tobramycin when inhaled using either PARI LC PLUS jet nebulizer or PARI eFlow rapid Electronic Nebulizer evaluated by serum concentrations
Status: Completed
Last Updated: 19 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 2006

End Date

TBD

Last Updated

19 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Novartis

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.

Outcomes

Primary Outcomes

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 Outcomes

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