Clincosm LogoSign in Get a demo

Tobramycin Administered by eFlow Rapid Nebulizer: Pharmacokinetic Study

Sponsor
Novartis (Industry)
Overall Status
Completed
CT.gov ID
NCT00420836
Collaborator
(none)
20
Enrollment

Study Details

Study Description

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
Phase 1

Study Design

Study Type:
Interventional
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 :
Apr 1, 2006

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years and Older
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Novartis

Investigators

  • Study Director: Novartis Basel, Novartis Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00420836
Other Study ID Numbers:
  • CTBM100B2201
First Posted:
Jan 11, 2007
Last Update Posted:
Jan 11, 2007
Last Verified:
Jan 1, 2007
Keywords provided by , ,
Cystic fibrosis, tobramycin, PARI eFlow, PARI LC Plus, nebulizer, pharmacokinetic
Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Tobramycin

Study Results

No Results Posted as of Jan 11, 2007