SESSION TITLE: Chest Infections
SESSION TYPE: Original Investigation Poster
PRESENTED ON: Wednesday, October 26, 2016 at 01:30 PM - 02:30 PM
PURPOSE: Post hoc analyses were conducted to describe stability and consistency of effect with LAI treatment over double-blind (DB) and open-label (OL) study periods in a phase 2 clinical trial.
METHODS: Patients with treatment-refractory nontuberculous mycobacterial (NTM) lung infection (Mycobacterium avium complex [MAC] and Mycobacterium abscessus [Mab]) on a stable multidrug regimen were randomized (1:1) to once-daily (QD) LAI 590 mg (LAI, n=44) or placebo (PLB, n=45) for 84 days of DB treatment followed by an additional 84 days of OL LAI (n=78) and assessed monthly. A safety assessment was performed during 28 days off treatment (n=64). The primary study endpoint was change in a Semi-Quantitative Scale (SQS) for mycobacterial colony counts using a score range of 1-7, with a score of 1 representing a negative culture. Stability and consistency of SQS scores and the rate of sputum culture negativity were evaluated with repeated measures mixed effects models, adjusted for baseline SQS.