Tobramycin Inhalation Solution Administered by eFlow Rapid Nebulizer: Scintigraphy Study (NCT00399945) | Clinical Trial Compass
CompletedPhase 1
Tobramycin Inhalation Solution Administered by eFlow Rapid Nebulizer: Scintigraphy Study
United Kingdom12 participantsStarted 2006-05
Plain-language summary
This study assesses the aerosol delivery characteristics (measured by in vivo lung deposition, nebulization time, serum tobramycin concentrations, and pharmacokinetic parameters) and safety of tobramycin inhalation solution administered for inhalation by PARI eFlow rapid electronic nebulizer (no compressor) vs. PARI LC PLUS Jet Nebulizer (with compressor) in healthy subjects and in subjects with cystic fibrosis.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
All subjects:
* Provide written informed consent prior to the performance of any study-related procedures.
* Be 18 to 65 years of age at screening.
* Weigh within ± 25% of the ideal using the body mass index method.
* Able to comply with all protocol requirements.
Healthy Subjects:
* Be healthy males or non-pregnant, non-breast-feeding healthy females.
* Have an forced expiratory volume in one second (FEV1) of at least 80% of predicted or greater based on age, sex, height, and race based on European Community for Steel and Coal (ECSC) equations
Subjects with Cystic Fibrosis:
* Be chronically colonized with Pseudomonas aeruginosa .
* Have a diagnosis of CF by documented sweat chloride of 60 mEq/L or greater by quantitative pilocarpine iontophoresis test (QPIT) and/or genotype with two identifiable mutations consistent with CF, accompanied by one or more clinical features consistent with CF.
* Have an FEV1 of 25% or more of the predicted value, calculated using ECSC equations based on age, sex, height, and race.
* Able to tolerate a 1-week washout interval with no inhaled tobramycin or other aminoglycoside treatment.
* Be clinically stable in the opinion of the referring investigator at the CF unit.
Exclusion Criteria:
All subjects:
* Participation in a clinical research study within the previous 1 month.
* History of alcohol or drug abuse.
* Positive result for drugs of abuse.
* Regular alcohol consumption in males and females of more than 21 units…
What they're measuring
1
Lung deposition of tobramycin when inhaled using either PARI LC PLUS jet nebulizer or PARI eFlow rapid Electronic Nebulizer