Tobramycin Administered by eFlow Rapid Nebulizer: Pharmacokinetic Study

Cystic Fibrosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00420836
• Other study ID #: CTBM100B2201
• Status: Completed
• Phase: Phase 1
• First received: January 10, 2007
• Last updated: January 10, 2007
• Start date: April 2006

Study information

• Verified date: January 2007
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence française de sécurité sanitaire des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Gender: Both
• Age group: 6 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Drug:
• Tobramycin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	Pharmacokinetics
Secondary	Safety assessed by adverse events, serious adverse events