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Dataset Information

Fosfomycin/tobramycin for inhalation in patients with cystic fibrosis with pseudomonas airway infection.


ABSTRACT:

Rationale

Fosfomycin/tobramycin for inhalation (FTI), a unique, broad-spectrum antibiotic combination, may have therapeutic potential for patients with cystic fibrosis (CF).

Objectives

To evaluate safety and efficacy of FTI (160/40 mg or 80/20 mg), administered twice daily for 28 days versus placebo, in patients greater than or equal to 18 years of age, with CF, chronic Pseudomonas aeruginosa (PA) airway infection, and FEV(1) greater than or equal to 25% and less than or equal to 75% predicted.

Methods

This double-blind, placebo-controlled, multicenter study assessed whether FTI/placebo maintained FEV(1) % predicted improvements achieved following a 28-day, open-label, run-in course of aztreonam for inhalation solution (AZLI).

Measurements and main results

A to

SUBMITTER: Trapnell BC 

PROVIDER: S-EPMC3361752 | biostudies-literature | 2012 Jan

REPOSITORIES: biostudies-literature