Liposomal Amikacin for Inhalation (LAI) for Nontuberculous Mycobacteria

"* Liposomal amikacin for inhalation is provided as a sterile aqueous liposomal dispersion for inhalation via nebulization.~* 590 mg of liposomal amikacin for inhalation is administered once daily using the PARI Investigational eFlow® Nebulizer.~* Administration time is approximately 13 minutes.~* Liposomal amikacin for inhalation will be administered for 84 days in the double-blind, randomized portion of the study.~* Subjects can continue with 84 additional days of dosing in the open label extension."

"* Placebo is provided as a sterile aqueous lipid dispersion for inhalation via nebulization.~* Administration procedures, volume and administration time are similar to LAI.~* Placebo will be administered for 84 days only during the double-blind, randomized portion of the study."