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Respiratory Care: Chest Infections |

Stability and Consistency of Treatment Effect With Liposomal Amikacin for Inhalation (LAI) as Add-on Therapy in Patients With Pulmonary Nontuberculous Mycobacterial (PNTM) Infection

Quanwu Zhang, PhD; George Georges, MD; John McGinnis, MPH; Keith Liu, PhD; Gina Eagle, MD; David Griffith, MD; Richard Wallace, MD; Kenneth Olivier, MD
Author and Funding Information

Insmed Incorporated, Bridgewater, NJ


Copyright 2016, American College of Chest Physicians. All Rights Reserved.


Chest. 2016;150(4_S):1235A. doi:10.1016/j.chest.2016.08.1347
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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.

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