- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00399945
Tobramycin Inhalation Solution Administered by eFlow Rapid Nebulizer: Scintigraphy Study
May 4, 2007 updated by: Novartis
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
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 Overview
Study Type
Interventional
Enrollment
12
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Stoke on Trent, United Kingdom
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Lung deposition of tobramycin when inhaled using either PARI LC PLUS jet nebulizer or PARI eFlow rapid Electronic Nebulizer
|
Secondary Outcome Measures
Outcome Measure |
---|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2006
Study Registration Dates
First Submitted
November 14, 2006
First Submitted That Met QC Criteria
November 14, 2006
First Posted (Estimate)
November 15, 2006
Study Record Updates
Last Update Posted (Estimate)
May 7, 2007
Last Update Submitted That Met QC Criteria
May 4, 2007
Last Verified
May 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CTBM100B2202
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cystic Fibrosis
-
Hospital de Clinicas de Porto AlegreUnknownCystic Fibrosis | Cystic Fibrosis Pulmonary Exacerbation | Cystic Fibrosis in Children | Cystic Fibrosis With ExacerbationBrazil
-
University of Colorado, DenverCystic Fibrosis FoundationTerminatedCystic Fibrosis-related Diabetes | Cystic Fibrosis Pulmonary Exacerbation | Cystic Fibrosis in ChildrenUnited States
-
Royal College of Surgeons, IrelandThe Hospital for Sick Children; Imperial College London; Erasmus Medical Center; University College Dublin and other collaboratorsActive, not recruitingCystic Fibrosis | Adherence, Medication | Cystic Fibrosis Gastrointestinal Disease | Cystic Fibrosis in Children | Cystic Fibrosis Liver DiseaseUnited Kingdom, Ireland
-
Herlev and Gentofte HospitalCopenhagen University Hospital, DenmarkActive, not recruitingMyocardial Infarction | Heart Diseases | Heart Failure | Stroke | Cystic Fibrosis | Heart Failure, Diastolic | Heart Failure, Systolic | Left Ventricular Dysfunction | Cystic Fibrosis-related Diabetes | Cystic Fibrosis Gastrointestinal Disease | Cystic Fibrosis of Pancreas | Cystic Fibrosis, Pulmonary | Cystic...Denmark
-
The Hospital for Sick ChildrenCanadian Cystic Fibrosis FoundationActive, not recruitingCystic Fibrosis | Cystic Fibrosis Gastrointestinal Disease | Cystic Fibrosis in ChildrenCanada
-
Arrowhead PharmaceuticalsTerminatedCystic Fibrosis, PulmonaryAustralia, New Zealand
-
AzurRx SASCompletedCystic Fibrosis | Cystic Fibrosis Gastrointestinal Disease | Cystic Fibrosis of PancreasTurkey, Hungary
-
Dartmouth-Hitchcock Medical CenterTrustees of Dartmouth CollegeWithdrawnCystic Fibrosis-related Diabetes | Cystic Fibrosis Liver Disease | CF - Cystic FibrosisUnited States
-
University Hospital, BordeauxCompleted
-
University of PortsmouthUniversity Hospital Southampton NHS Foundation Trust; Loughborough University; Queen Alexandra HospitalTerminated
Clinical Trials on Tobramycin
-
University of North Carolina, Chapel HillCystic Fibrosis FoundationCompletedCystic Fibrosis
-
Pari Pharma GmbHCompleted
-
Novartis PharmaceuticalsCompletedCystic FibrosisUnited States, Germany, United Kingdom, Colombia, Spain, France, Netherlands, Israel, Canada, Italy, Chile, Australia, Hungary, Mexico
-
FDA Office of Orphan Products DevelopmentCompletedCystic Fibrosis | Bacterial Infection
-
Erik Allen JensenUniversity of FloridaActive, not recruiting
-
Chiesi Farmaceutici S.p.A.CompletedCystic FibrosisSpain, Ukraine, Czechia, France, Germany, Hungary, Poland, Russian Federation
-
University of MilanChiesi Farmaceutici S.p.A.Completed
-
NovartisCompletedPseudomonas InfectionsGermany
-
National Institute of Diabetes and Digestive and...National Center for Research Resources (NCRR)CompletedCystic FibrosisUnited States
-
Novartis PharmaceuticalsCompletedCystic FibrosisSpain, Germany, Switzerland, United Kingdom, Ireland