Tobramycin Administered by eFlow Rapid Nebulizer: Pharmacokinetic Study - Full Text View

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00420836

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 I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Bio-equivalence Study
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:

Genetics Home Reference related topics: cystic fibrosis

MedlinePlus related topics: Cystic Fibrosis

Drug Information available for: Tobramycin Tobramycin sulfate

U.S. FDA Resources

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

Study ID Numbers:	CTBM100B2201
Study First Received:	January 10, 2007
Last Updated:	January 10, 2007
ClinicalTrials.gov Identifier:	NCT00420836 History of Changes
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:

Anti-Infective Agents
Tobramycin
Fibrosis
Pharmacologic Actions
Anti-Bacterial Agents
Digestive System Diseases
Pathologic Processes

Cystic Fibrosis
Respiratory Tract Diseases
Genetic Diseases, Inborn
Lung Diseases
Therapeutic Uses
Pancreatic Diseases
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on February 08, 2010