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

University of Milan

Status and phase: Completed; Phase 4

Conditions: Cystic Fibrosis

Treatments: Drug: tobramycin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01608555

SP2

2011-001821-26 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

inhaled tobramycin once-a-day

Experimental group

Description:

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.

Treatment:

Drug: tobramycin