Overview

Phase III Randomized Study of the Inhalation of Tobramycin in Patients With Cystic Fibrosis

Status:
Completed
Trial end date:
1998-05-01
Target enrollment:
Participant gender:
Summary
OBJECTIVES: I. Determine the safety and efficacy of tobramycin in patients with cystic fibrosis who are chronically colonized with Pseudomonas aeruginosa. II. Determine whether this treatment produces tobramycin-resistant bacteria at a frequency different from the placebo group and whether the emergence of resistance is associated with a lack of clinical response.
Phase:
Phase 3
Details
Lead Sponsor:
FDA Office of Orphan Products Development
Treatments:
Tobramycin