Liposomal Amikacin for Inhalation (LAI) in the Treatment of Mycobacterium Abscessus Lung Disease

Inclusion Criteria: * Male or female patients 12 years and older * Diagnosis of M. abscessus, including all subspecies, abscessus, bolleti, and massiliense lung disease according to the 2007 ATS/IDSA criteria * Both newly diagnosed and currently on treatment or previously treated patients will be included * Culture positive (either sputum or bronchoscopy) for M. abscessus at time of screening * Willingness to adhere to a treatment regimen, study visits, and study procedures during the course of the study. * Ability to produce at approximately 3.0 mL of sputum or be willing to undergo an induction that produces approximately 3.0 mL of sputum for culture collection * Female of childbearing potential agrees to practice an acceptable method of birth control (e.g., abstinence, hormonal or barrier methods, partner sterilization, or IUD) * Written informed consent or assent obtained from the patient, parent or legal guardian prior to the performance of any study related procedures Exclusion Criteria: * Active pulmonary tuberculosis requiring treatment at screening * Treatment with inhaled or intravenous Amikacin within 14 days prior to baseline * Known hypersensitivity to aminoglycosides * Aspartate aminotransferase or alanine aminotransferase ≥ 3 times the upper limit of normal or total bilirubin ≥ 2 times the upper limit of normal (ULN) at screening * Current addiction to alcohol or illicit drug abuse * Any condition which in the opinion of the Investigator interferes with abil…