Tobramycin Administered by eFlow Rapid Nebulizer: Pharmacokinetic Study
Information source: Novartis
Information obtained from ClinicalTrials.gov on June 20, 2008
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
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: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Bio-equivalence Study
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
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