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Completed

NCT Number: NCT00420836

Tobramycin Administered by eFlow Rapid Nebulizer: Pharmacokinetic Study

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.

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Key information

Conditions

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

Age range

6 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tobramycin

Drug

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

  1. 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.

  2. Pharmacokinetics

  3. Safety assessed by adverse events, serious adverse events

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study 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

Important dates

Study start
2006
First posted
Jan 11, 2007
Registry last updated
Jan 11, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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