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 range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Trial details

NCT IDNCT00399945

SponsorNovartis

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

View on ClinicalTrials.gov More Cystic Fibrosis trials