12-Month Follow-up From Phase 2 Trial of Liposomal Amikacin for Inhalation (LAI) in Patients With Nontuberculous Mycobacterial (NTM) Lung Infection
K Olivier, D Griffith, K Winthrop, B Brown-Elliott, G Eagle, J McGinnis, R Wallace · Pneumologie · 2016 · Heft 10
Bibliografische Angaben
Zusammenfassung
Introduction: TR02 – 112 enrolled adult patients with NTM lung infection due to MAC and/or Mycobacterium abscessus refractory to a multi-drug regimen for ≥6 months. The randomized, placebo-controlled study evaluated efficacy, safety, and tolerability of LAI 590 mg administered once daily added to multi-drug regimen for 84 days (Double-blind). Patients continuing in the Open-label phase received LAI added to multi-drug regimen for 84 additional days. Here we report long term safety and efficacy data collected for patients in the 12 months after the last dose of LAI. Methods: The follow-up period was included to a…