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

Phase 4

Completed

• Conditions: Cystic Fibrosis
• Interventions: Drug: tobramycin

• Registration Number: NCT01608555
• Lead Sponsor: University of Milan

Brief Summary

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

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 Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-05-28
• Study First Submitted QC: 2012-05-30
• Study First Posted: 2012-05-31
• Status Verified: 2012-07
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Last Update Submitted: 2012-07-23
• Last Update Posted: 2012-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
inhaled tobramycin once-a-day	tobramycin	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Evaluation of inflammatory serum biomarker	day7-9 vs day 1, Day 14-16 vs day 7-9, Day 28-30 vs 14-16	Serum levels of biomarker (PCT) will be evaluated during and at the end of treatment
Evaluation of serum biomarker	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
evaluation of serum biomarker	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

Trial Locations

Locations (1)

IRCCS Ospedale Maggiore Policlinico via F. Sforza 35; 🇮🇹 Milan, Italy