Cystic FibrosisPhase 1NCT00399945
Tobramycin Inhalation Solution Administered by eFlow Rapid Nebulizer: Scintigraphy Study
A Phase 1 study testing Tobramycin in people with Cystic Fibrosis, run by Novartis at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Tobramycin
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2006to not given
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Tobramycin
- Keywords
- Cystic fibrosis, tobramycin, PARI eFlow, PARI LC Plus, nebulizer, pharmacoscintigraphy
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TobramycinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2006 (estimated)
- Study startMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis, Study director, Novartis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00399945
- Sponsor's protocol ID
- CTBM100B2202
- Status last verified
- May 2007
- First submitted
- 14 Nov 2006
- Last updated
- 7 May 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00399945
- Acronym / sponsor ID
- CTBM100B2202
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic fibrosis, tobramycin, PARI eFlow, PARI LC Plus, nebulizer, pharmacoscintigraphy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- May 2006
- First posted
- 15 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
- Be healthy males or non-pregnant, non-breast-feeding healthy females.
Key exclusion criteria (33 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tobramycin | Drug | – |
Primary outcome
Lung deposition of tobramycin when inhaled using either PARI LC PLUS jet nebulizer or PARI eFlow rapid Electronic Nebulizer
3 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis study director
Novartis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tobramycin in people with Cystic Fibrosis, run by Novartis at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung deposition of tobramycin when inhaled using either PARI LC PLUS jet nebulizer or PARI eFlow rapid Electronic Nebulizer. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2007.