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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00420836 |
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Date of registration:
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10/01/2007 |
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Primary sponsor: |
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Public title:
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Tobramycin Administered by eFlow Rapid Nebulizer: Pharmacokinetic Study
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Scientific title:
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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 |
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Date of first enrolment:
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April 2006 |
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Target sample size:
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20 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00420836 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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Contacts
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Name:
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Novartis Basel |
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Address:
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Telephone:
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Email:
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Affiliation:
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Novartis Pharmaceuticals |
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Key inclusion & exclusion criteria
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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.
Age minimum:
6 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cystic Fibrosis
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Intervention(s)
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Drug: Tobramycin
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Primary Outcome(s)
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Aerosol delivery characteristics of tobramycin when inhaled using either PARI LC PLUS jet nebulizer or PARI eFlow rapid Electronic Nebulizer evaluated by serum concentrations
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Secondary Outcome(s)
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Pharmacokinetics
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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.
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Safety assessed by adverse events, serious adverse events
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Secondary ID(s)
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CTBM100B2201
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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