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Tobramycin Inhalation Solution Administered by eFlow Rapid Nebulizer: Scintigraphy Study

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cystic Fibrosis

Intervention: Tobramycin (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis, Study Director, Affiliation: Novartis

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.

Clinical Details

Official title: 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

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

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

Secondary outcome:

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

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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 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.

Healthy Subjects:

- Screening FEV1 less than 80% of the predicted value for sex, age, height, and race

using ECSC equations

- History of chronic respiratory disorders, including asthma.

- Treatment with tobramycin or other aminoglycosides within 1 week prior to the study.

- History of adverse reaction or allergy to tobramycin or other aminoglycosides.

- History of infantile bronchiolitis or a history or the presence of asthma or wheezy

respiration.

- Upper respiratory tract infection (excluding otitis media) within 14 days of the

first study day or lower respiratory tract infection within the last 3 months.

- Treatment with any medication that may affect the respiratory tract within 1 week of

the first study day and throughout the study (oral contraceptives, Hormone Replacement Therapy [HRT], and paracetamol are permitted);

- Failure to satisfy the Principal Investigator regarding fitness to participate for

any other reason.

- Donation of blood within the previous 3 months.

- Treatment with diuretics or history of renal failure.

- Radiation exposure from clinical trials. No subject whose occupational exposure is

monitored is eligible to participate in the study. Subjects with Cystic Fibrosis:

- Screening FEV1 less than 25% of the predicted value for sex, age, height, and race

using ECSC equations

- Treatment with inhaled or intravenous aminoglycosides within 7 days before study drug

administration.

- Current treatment with inhaled tobramycin delivered by the PARI LC PLUS jet nebulizer

who do not have a washout period of at least 1 week before entering the study.

- Hemoptysis more than 60 mL at any time within 30 days before study drug

administration. Other protocol-defined inclusion/exclusion criteria may apply

Locations and Contacts

Stoke on Trent, United Kingdom
Additional Information

Starting date: May 2006
Last updated: May 4, 2007

Page last updated: August 23, 2015

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