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

• Status: Completed
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Milan
• Collaborator: Chiesi Farmaceutici S.p.A.
• Treatments: Tobramycin

Criteria

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