drugset / Trial / NCT00794586
Study Evaluating Fosfomycin/Tobramycin for Inhalation in Cystic Fibrosis Patients With Pseudomonas Aeruginosa Lung Infection
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to evaluate the safety and efficacy of 2 dose combinations of fosfomycin/tobramycin for inhalation (FTI), following a 28-day course of Aztreonam for Inhalation (AZLI) in patients with cystic fibrosis and Pseudomonas aeruginosa lung infection.
Timeline
- Start
- 2008-11
- Primary completion
- 2010-02
- Completion
- 2010-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fosfomycin | Small molecule | 80 mg | Inhaled |
| Subject | Fosfomycin | Small molecule | 160 mg | Inhaled |
| Subject | Tobramycin | Small molecule | 20 mg | Inhaled |
| Subject | Tobramycin | Small molecule | 40 mg | Inhaled |
| Comparator | Aztreonam | Small molecule | — | Inhaled |