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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01608555

Enrollment

Registered

2012-05-31

Start date

2012-01-31

Completion date

2012-07-31

Last updated

2012-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis

Keywords

cystic fibrosis, bacterial load, inhaled tobramycin

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.

Interventions

DRUGtobramycin

inhaled tobramycin 300 mg single dose OD for 28 days

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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 C-reactive protein 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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026