The purpose of this study is to evaluate the long term safety and tolerability of Liposomal Amikacin for Inhalation (LAI) 590 mg once daily (QD) in Cystic Fibrosis patients with chronic infection due to pseudomonas aeruginosa. This long-term, open-label, multi-cycle extension study enrolled subjects who had successfully completed study TR02-108, were compliant with the study protocol, and did not meet any of the listed study discontinuation criteria. The safety and tolerability of LAI were evaluated for up to approximately 2 years.
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Treatment Emergent Adverse Events (TEAEs) up to Day 672
Timeframe: From Study Initiation up to Day 672
Laboratory Abnormalities up to Day 672
Timeframe: Baseline, Day 377 and Day 672
Acute Tolerability as Measured by Pulmonary Function Test (PFT) Changes Pre to Post Dose
Timeframe: Day 1, Day 84, Day 196, Day 281, Day 337, Day 449, Day 532 and Day 644
Respiratory Rate: Change From Baseline to Day 672
Timeframe: From Study Initiation up to Day 672
Heart Rate: Change From Baseline From Day 672
Timeframe: From Study Initiation up to Day 672
Systolic BP: Change From Baseline at Day 672
Timeframe: From Study Initiation up to Day 672
Diastolic BP: Change From Baseline at Day 672
Timeframe: From Study Initiation up to Day 672
Body Temperature: Change From Baseline at Day 672
Timeframe: From Study Initiation up to Day 672
Oxygen Saturation: Change From Baseline at Day 672
Timeframe: From Study Initiation up to Day 672
Minimum Inhibitory Concentrations (MICs) for Pseudomonas Aeruginosa (Pa) and Burkholderia Species From Day 1 to Days 169, 337, 505 and 672
Timeframe: Day 1, Day 169, Day 337, Day 505 and Day 672
Evaluation of Audiology
Timeframe: Day 337 and Day 672
Change in Serum Creatinine Throughout the Study
Timeframe: Baseline, Day 337 and Day 672