Tobramycin inhalation powder manufactured by improved process in cystic fibrosis: the randomized EDIT trial.

ABSTRACT:

Background

Tobramycin inhalation powder (TIP) was reported to be effective in two Phase III studies in patients with cystic fibrosis (CF) chronically infected with Pseudomonas aeruginosa (Pa). The EDIT study evaluated the efficacy and safety of TIP manufactured by an improved process in CF subjects aged 6-21 years.

Methods

CF patients with a forced expiratory volume in 1 second (FEV₁) ≥25% to ≤80% predicted, positive Pa cultures and inhaled antipseudomonal therapy naïve (or at least for past 4 months) were enrolled into this double-blind, multicenter trial. Patients were randomized to receive TIP or placebo (1:1) twice daily for one treatment cycle (28.5 days on drug, 28 days off drug). The primary endpoint was relative change in FEV₁ percentage predicted from baseline to da

SUBMITTER: Galeva I 

PROVIDER: S-EPMC4086187 | biostudies-literature | 2013 Aug

REPOSITORIES: biostudies-literature