Tobramycin Administered by eFlow Rapid Nebulizer: Pharmacokinetic Study

Novartis

Status and phase

Completed

Phase 1

Conditions

Cystic Fibrosis

Treatments

Drug: Tobramycin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00420836

CTBM100B2201

Details and patient eligibility

About

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.

Sex

All

Ages

6+ years old

Volunteers

No Healthy Volunteers

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.