- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01608555
Tobramycin 300 mg Once-a-day (o.d.) Aerosol in Adults With Cystic Fibrosis
July 23, 2012 updated by: Francesco Blasi, University of Milan
Tobramycin 300 mg o.d. Aerosol in in Adult Patients With Cystic Fibrosis: Pilot Study on Antimicrobial Activity
The study will include 10 adult patients with cystic fibrosis.
The aim of the study is to evaluate whether Tobramycin 300 mg aerosol once-a-day for 28 days can reduce the bacterial load in the airways.
Secondary end-point is the evaluation of variation in bacterial susceptibility during and at the end of study period.
Study Overview
Detailed Description
Ten adult patients with cystic fibrosis will be enrolled in a stable phase and will received prophylaxis with aerosol of Tobramycin 300 mg once a day for 28 days.
Study Type
Interventional
Enrollment (Anticipated)
10
Phase
- Phase 4
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
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Milan, Italy, 20122
- IRCCS Ospedale Maggiore Policlinico via F. Sforza 35
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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
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Outpatients, male and female, age range 18-45 years
- Diagnosis of cystic fibrosis
- FEV1 >50% predicted.
- sputum samples available
- Chest x ray negative for pneumonia and tuberculosis
- Informed consent
Exclusion Criteria:
- Allergy to tobramycin
- Use of systemic steroids in the previous 2 weeks
- Pregnancy or breast feeding
- Treatment with other experimental drug in the previous 3 months
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: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: inhaled tobramycin once-a-day
Adult patients, with cystic fibrosis, requiring inhaled tobramycin prophylaxis.
Patient will be treated with a single dose of 300 mg tobramycin od for 28 days.
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inhaled tobramycin 300 mg single dose OD for 28 days
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of bacterial load decrease
Time Frame: day 7-9 vs day 1, day 14-16 vs day 7-9, day 28-30 vs day 14-26
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Bacterial load in sputum will be evaluated during and at the end of treatment
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day 7-9 vs day 1, day 14-16 vs day 7-9, day 28-30 vs day 14-26
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of inflammatory serum biomarker
Time Frame: day7-9 vs day 1, Day 14-16 vs day 7-9, Day 28-30 vs 14-16
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Serum levels of biomarker (PCT) will be evaluated during and at the end of treatment
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day7-9 vs day 1, Day 14-16 vs day 7-9, Day 28-30 vs 14-16
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Evaluation of serum biomarker
Time Frame: day7-9 vs day 1, Day 14-16 vs day 7-9, Day 28-30 vs 14-16
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Evaluation of C-reactive protein levels during and at the end of treatment
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day7-9 vs day 1, Day 14-16 vs day 7-9, Day 28-30 vs 14-16
|
Evaluation of serum biomarker
Time Frame: day7-9 vs day 1, Day 14-16 vs day 7-9, Day 28-30 vs 14-16
|
Evaluation of KL6 levels during and at the end of treatment
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day7-9 vs day 1, Day 14-16 vs day 7-9, Day 28-30 vs 14-16
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evaluation of serum biomarker
Time Frame: day7-9 vs day 1, Day 14-16 vs day 7-9, Day 28-30 vs 14-16
|
Evaluation of interleukin 6 during and at the end of treatment
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day7-9 vs day 1, Day 14-16 vs day 7-9, Day 28-30 vs 14-16
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Giovanna Pizzamiglio, MD, University of Milan Italy
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
January 1, 2012
Primary Completion (Actual)
July 1, 2012
Study Completion (Actual)
July 1, 2012
Study Registration Dates
First Submitted
May 28, 2012
First Submitted That Met QC Criteria
May 30, 2012
First Posted (Estimate)
May 31, 2012
Study Record Updates
Last Update Posted (Estimate)
July 24, 2012
Last Update Submitted That Met QC Criteria
July 23, 2012
Last Verified
July 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SP2
- 2011-001821-26 (EudraCT Number)
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
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Hospital de Clinicas de Porto AlegreUnknownCystic Fibrosis | Cystic Fibrosis Pulmonary Exacerbation | Cystic Fibrosis in Children | Cystic Fibrosis With ExacerbationBrazil
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University of Colorado, DenverCystic Fibrosis FoundationTerminatedCystic Fibrosis-related Diabetes | Cystic Fibrosis Pulmonary Exacerbation | Cystic Fibrosis in ChildrenUnited States
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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
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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
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The Hospital for Sick ChildrenCanadian Cystic Fibrosis FoundationActive, not recruitingCystic Fibrosis | Cystic Fibrosis Gastrointestinal Disease | Cystic Fibrosis in ChildrenCanada
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Arrowhead PharmaceuticalsTerminatedCystic Fibrosis, PulmonaryAustralia, New Zealand
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AzurRx SASCompletedCystic Fibrosis | Cystic Fibrosis Gastrointestinal Disease | Cystic Fibrosis of PancreasTurkey, Hungary
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Dartmouth-Hitchcock Medical CenterTrustees of Dartmouth CollegeWithdrawnCystic Fibrosis-related Diabetes | Cystic Fibrosis Liver Disease | CF - Cystic FibrosisUnited States
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University Hospital, BordeauxCompleted
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University of PortsmouthUniversity Hospital Southampton NHS Foundation Trust; Loughborough University; Queen Alexandra HospitalTerminated
Clinical Trials on tobramycin
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University of North Carolina, Chapel HillCystic Fibrosis FoundationCompletedCystic Fibrosis
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Pari Pharma GmbHCompleted
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Novartis PharmaceuticalsCompletedCystic FibrosisUnited States, Germany, United Kingdom, Colombia, Spain, France, Netherlands, Israel, Canada, Italy, Chile, Australia, Hungary, Mexico
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FDA Office of Orphan Products DevelopmentCompletedCystic Fibrosis | Bacterial Infection
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Chiesi Farmaceutici S.p.A.CompletedCystic FibrosisSpain, Ukraine, Czechia, France, Germany, Hungary, Poland, Russian Federation
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Erik Allen JensenUniversity of FloridaActive, not recruiting
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NovartisCompletedPseudomonas InfectionsGermany
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National Institute of Diabetes and Digestive and...National Center for Research Resources (NCRR)CompletedCystic FibrosisUnited States
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Novartis PharmaceuticalsCompletedCystic FibrosisSpain, Germany, Switzerland, United Kingdom, Ireland
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University of NottinghamCompletedCystic FibrosisUnited Kingdom