Safety, efficacy and convenience of tobramycin inhalation powder in cystic fibrosis patients: The EAGER trial.

ABSTRACT:

Background

A light-porous-particle, dry-powder formulation of tobramycin was developed, using PulmoSphere® technology, to improve airway delivery efficiency, substantially reduce delivery time, and improve patient convenience and satisfaction. We evaluated the safety, efficacy and convenience of tobramycin inhalation powder (TIP™) versus tobramycin inhalation solution (TIS, TOBI®) for treating Pseudomonas aeruginosa infection in cystic fibrosis (CF) patients aged ≥6 years.

Methods

In this open-label study, 553 patients were randomized 3:2 to TIP (total 112mg tobramycin) via the Novartis T-326 Inhaler or TIS 300mg/5mL via PARI LC® PLUS nebulizer twice daily for three treatment cycles (28 days on-drug, 28 days off-drug). Safety, efficacy, and treatment satisfaction outcomes we

SUBMITTER: Konstan MW 

PROVIDER: S-EPMC4086197 | biostudies-literature | 2011 Jan

REPOSITORIES: biostudies-literature