NCT00399945
Completed
Phase 1
A Phase 1, Single-Dose, Open-Label, Two-Way Crossover, Pharmacoscintigraphy Study of Aerosol Delivery Characteristics (Measured by In Vivo Lung Deposition, Nebulization Time, Serum Tobramycin Concentrations, and Pharmacokinetic Parameters) and Safety of Tobramycin Administered for Inhalation by PARI eFlow® Rapid Electronic Nebulizer (No Compressor) vs. PARI LC PLUS (TM) Jet Nebulizer (With Compressor) in Healthy Subjects and in Subjects With Cystic Fibrosis
ConditionsCystic Fibrosis
DrugsTobramycin
Overview
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Novartis
- Enrollment
- 12
- Primary Endpoint
- Lung deposition of tobramycin when inhaled using either PARI LC PLUS jet nebulizer or PARI eFlow rapid Electronic Nebulizer
Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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 .
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 and 14 units per week, respectively
- •Known hypersensitivity to salbutamol.
- •Current smoker or smoked within the last 12 months.
- •Breath carbon monoxide reading of greater than 10 ppm either at the prestudy medical examination or on a study day prior to dosing.
- •Females of childbearing potential, who are pregnant who plan to become pregnant during the course of the study, who are breast feeding, or who are sexually active and either not using a reliable form of contraception or not surgically sterile.
- •Clinically significant abnormal biochemistry, hematology, or urinalysis.
Outcomes
Primary Outcomes
Lung deposition of tobramycin when inhaled using either PARI LC PLUS jet nebulizer or PARI eFlow rapid Electronic Nebulizer
Secondary Outcomes
- Nebulisation time for inhaling tobramycin using PARI LC PLUS jet nebulizer or PARI eFlow rapid Electronic Nebulizer
- Correlation between tobramycin deposition and serum tobramycin concentrations and pharmacokinetics
- Safety of tobramycin when inhaled using either PARI LC PLUS jet nebulizer or PARI eFlow rapid Electronic Nebulizer
Investigators
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