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Amikacin liposome inhalation suspension in newly diagnosed Mycobacterium avium complex lung disease (ARISE): a 6-month double-blind, active comparator trial - PubMed

6 hours ago
  • #Amikacin liposome inhalation suspension
  • #Clinical trial
  • #Mycobacterium avium complex
  • ALIS (amikacin liposome inhalation suspension) is tested in newly diagnosed MACLD patients.
  • The ARISE trial is a 6-month double-blind study comparing ALIS plus azithromycin and ethambutol to an empty liposome control plus the same antibiotics.
  • Culture conversion rates were higher with ALIS: 80.6% by month 6 vs. 63.9% with comparator.
  • Most ALIS patients achieving conversion had their first negative culture by month 1.
  • Quality of Life-Bronchiectasis Respiratory Domain scores improved with ALIS, while the comparator plateaued after month 3.
  • Fatigue scores improved in both groups without significant difference between arms.
  • No serious adverse events or deaths related to ALIS were reported.
  • The study confirms ALIS efficacy in culture conversion and shows no new safety concerns.