Phase III Randomized Study of the Inhalation of Tobramycin in Patients With Cystic Fibrosis
|ClinicalTrials.gov Identifier: NCT00004829|
Recruitment Status : Completed
First Posted : February 25, 2000
Last Update Posted : March 25, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Cystic Fibrosis Bacterial Infection||Drug: tobramycin||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||200 participants|
|Study Start Date :||June 1995|
|Study Completion Date :||May 1998|
U.S. FDA Resources
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004829
|Study Chair:||Alan Bruce Montgomery||Pathogenesis|