Tobramycin Administered by eFlow Rapid Nebulizer: Pharmacokinetic Study

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00420836
First received: January 10, 2007
Last updated: NA
Last verified: January 2007
History: No changes posted
  Purpose

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 Intervention Phase
Cystic Fibrosis
Drug: Tobramycin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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:
  • 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

Estimated Enrollment: 20
Study Start Date: April 2006
  Eligibility

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00420836

Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Basel Novartis Pharmaceuticals
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00420836     History of Changes
Other Study ID Numbers: CTBM100B2201
Study First Received: January 10, 2007
Last Updated: January 10, 2007
Health Authority: France: Agence française de sécurité sanitaire des produits de santé

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

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

ClinicalTrials.gov processed this record on April 17, 2014