TR02-110

• Incidence of treatment emergent adverse events 
  Treatment emergent adverse events including serious adverse events and adverse events leading to permanent discontinuation of study drug
• Relative change in FEV1 [liters] and FEV1 % predicted
• Acute tolerability as measured by PFT changes pre- to post-dose 

• Time to first protocol defined pulmonary exacerbation and proportion of subjects experiencing a protocol defined pulmonary exacerbation 
• Time to first antipseudomonal antibiotic treatment for protocol defined pulmonary exacerbation, proportion of subjects initiating treatment and number of days of treatment 
• Shift in minimum inhibitory concentration for Pseudomonas aeruginosa throughout the study
  
  
• Evaluation of emergent pathogens 

• Written informed consent or assent
• Subject has completed study TR02-108, and has been compliant with the study protocol
• Women of childbearing potential must agree to use reliable methods of contraception for the duration of the study

• Subject met any of the listed criteria for study drug discontinuation in protocol TR02-108.
• Abnormal laboratory assessments including LFT (≥ 3× ULN), serum creatinine (> 2× ULN) and ANC (< 1000).
• Psychotic, addictive or other disorder limiting the ability to provide informed consent or to comply with study requirements.
• History of alcohol, medication or illicit drug abuse within the 6 months prior to consent.
• Smoking tobacco or any substance within 6 months prior to consent or anticipated inability to refrain from smoking throughout the study

Experimental: Arikace™

Drug: Liposomal amikacin for inhalation

• Liposomal amikacin for inhalation is provided as a sterile aqueous liposomal dispersion for inhalation via Nebulization.
• 560 mg of liposomal amikacin for inhalation is administrated once daily using the PARI Investigational eFlow® Nebulizer.
• Administration time is approximately 13 minutes.
• Liposomal amikacin for inhalation will be administered in two consecutive extension periods, each consisting of 6 cycles for a total of 12 cycles. Each cycle consists of 28 days on-treatment follow by 28 days off-treatment.