Tobramycin Administered by eFlow Rapid Nebulizer: Pharmacokinetic Study

NCT00420836 | Completed Phase 1

• 1 other identifier: CTBM100B2201
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cystic Fibrosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 (3)

• 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

Interventions

Tobramycin DRUG

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis: lead

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Tobramycin

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Nebramycin; Kanamycin; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Novartis Basel

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 10, 2007
• First Posted: January 11, 2007
• Study Start: April 1, 2006
• Last Updated: January 11, 2007

Record last verified: 2007-01