Phase III Randomized Study of the Inhalation of Tobramycin in Patients With Cystic Fibrosis
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|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)|
|Estimated Enrollment :||200 participants|
|Study Start Date :||June 1995|
|Estimated Study Completion Date :||May 1998|
U.S. FDA Resources
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004829
|Study Chair:||Alan Bruce Montgomery||Pathogenesis|