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Tobramycin Administered by eFlow Rapid Nebulizer: Pharmacokinetic Study

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cystic Fibrosis

Intervention: Tobramycin (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis Basel, Study Director, Affiliation: Novartis Pharmaceuticals

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 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:

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

Eligibility

Minimum age: 6 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Additional Information

Starting date: April 2006
Last updated: January 10, 2007

Page last updated: August 23, 2015

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