Tobramycin 300 mg Once-a-day (o.d.) Aerosol in Adults With Cystic Fibrosis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Tobramycin 300 mg o.d. Aerosol in in Adult Patients With Cystic Fibrosis: Pilot Study on Antimicrobial Activity

Conditions
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Cystic Fibrosis

Intervention / Treatment
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* Drug: tobramycin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: inhaled tobramycin once-a-day<br>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. | Drug: tobramycin<br>* inhaled tobramycin 300 mg single dose OD for 28 days<br>* Other names: Bramitob;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of bacterial load decrease | Bacterial load in sputum will be evaluated during and at the end of treatment | day 7-9 vs day 1, day 14-16 vs day 7-9, day 28-30 vs day 14-26 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of inflammatory serum biomarker | Serum levels of biomarker (PCT) will be evaluated during and at the end of treatment | day7-9 vs day 1, Day 14-16 vs day 7-9, Day 28-30 vs 14-16 | 
| Evaluation of serum biomarker | Evaluation of C-reactive protein levels during and at the end of treatment | day7-9 vs day 1, Day 14-16 vs day 7-9, Day 28-30 vs 14-16 | 
| Evaluation of serum biomarker | Evaluation of KL6 levels during and at the end of treatment | day7-9 vs day 1, Day 14-16 vs day 7-9, Day 28-30 vs 14-16 | 
| evaluation of serum biomarker | Evaluation of interleukin 6 during and at the end of treatment | day7-9 vs day 1, Day 14-16 vs day 7-9, Day 28-30 vs 14-16 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cystic fibrosis, bacterial load, inhaled tobramycin