Tobramycin Inhalation Solution Administered by eFlow Rapid Nebulizer: Scintigraphy Study

NCT00399945 | Completed Phase 1

• 1 other identifier: CTBM100B2202
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis

Keywords

Cystic fibrosis, tobramycin, PARI eFlow, PARI LC Plus, nebulizer, pharmacoscintigraphy

Outcome Measures

Primary Outcomes (1)

• Lung deposition of tobramycin when inhaled using either PARI LC PLUS jet nebulizer or PARI eFlow rapid Electronic Nebulizer

Secondary Outcomes (3)

• 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

Interventions

Tobramycin DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Positive hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV) results.
• Treatment with any investigational drug within 1 month before screening.
• Treatment with loop diuretics within 7 days before study drug administration.
• Serum creatinine or blood urea above the upper limit of normal for sex and age, or an abnormal urine analysis defined as 2+ or greater proteinuria.
• Known local or systemic hypersensitivity to aminoglycosides.

Sponsors & Collaborators

• Novartis: lead

Study Sites (1)

Unknown Facility

Stoke-on-Trent, United Kingdom

Location

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Tobramycin

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Nebramycin; Kanamycin; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Novartis

  Novartis

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 14, 2006
• First Posted: November 15, 2006
• Study Start: May 1, 2006
• Last Updated: May 7, 2007

Record last verified: 2007-05

Locations

GB (1)