Tobramycin Administered by eFlow Rapid Nebulizer: Pharmacokinetic Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00420836
Recruitment Status : Completed
First Posted : January 11, 2007
Last Update Posted : January 11, 2007
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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.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Drug: Tobramycin Phase 1

Study Type : Interventional  (Clinical Trial)
Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : April 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis
U.S. FDA Resources

Primary Outcome Measures :
  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 Outcome Measures :
  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

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Ages Eligible for Study:   6 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00420836

Sponsors and Collaborators
Study Director: Novartis Basel Novartis Pharmaceuticals Identifier: NCT00420836     History of Changes
Other Study ID Numbers: CTBM100B2201
First Posted: January 11, 2007    Key Record Dates
Last Update Posted: January 11, 2007
Last Verified: January 2007

Keywords provided by Novartis:
Cystic fibrosis, tobramycin, PARI eFlow, PARI LC Plus, nebulizer, pharmacokinetic

Additional relevant MeSH terms:
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Anti-Bacterial Agents
Anti-Infective Agents