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A Phase 2, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial Evaluating Fosfomycin/Tobramycin for Inhalation in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa
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.
Details
| Lead sponsor | Gilead Sciences |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 120 |
| Start date | 2008-11 |
| Completion | 2010-03 |
Conditions
- Cystic Fibrosis
Interventions
- FTI, AZLI
- Placebo, AZLI
Primary outcomes
- Relative change in lung function from baseline at Day 28. — 28 Days
Countries
United States