NCT00004829

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (planned)
• Sponsor: FDA Office of Orphan Products Development · Federal
• Sex: All
• Age: 6 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients receive tobramycin or placebo by inhalation twice daily for 28 days followed by 28 days of rest. This treatment is repeated twice, for a total of 3 courses of therapy. Patients are followed every 2 weeks for the first 8 weeks, then every 4 weeks, and then at 4 weeks after the last treatment.

Conditions

• Cystic Fibrosis
• Bacterial Infection

Interventions

Type	Name	Description
DRUG	tobramycin

Timeline

• Start date: 1995-06-01
• Completion: 1998-05-01
• First posted: 2000-02-25
• Last updated: 2015-03-25