Inhaled Therapy Boosts Lung Disease Treatment Success
New clinical trial data indicates adding amikacin to standard therapy significantly improves culture conversion rates.
Updated on Oct. 21, 2026 in Asthma
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Researchers reported that incorporating amikacin liposome inhalation suspension into multidrug regimens increases culture conversion in patients with Mycobacterium avium complex lung disease. The findings also suggest that early multidrug therapy reduces hospitalization risks for these patients.
Why it matters
Investigators sought to determine if adding inhaled amikacin to standard treatment could improve clinical outcomes while minimizing the development of drug resistance. This approach aims to address the challenges of managing chronic nontuberculous mycobacteria pulmonary infections.
The ENCORE trial enrolled 425 participants, with 76.2% in the ALIS arm achieving durable culture conversion compared to 47.6% in the control group. Resistance to treatment remained low, with only 2.2% developing emergent amikacin resistance.
The players
Oregon Health & Science University
This is a public research university and academic health center based in Portland that conducts extensive clinical and scientific studies.
Food and Drug Administration
This federal agency is responsible for protecting public health by ensuring the safety, efficacy, and security of human drugs and biological products.
The details
Participants in the trial received once-daily azithromycin and ethambutol combined with either 590 mg of ALIS or an empty liposome. Real-world analysis of 5,370 adult patient claims further showed that active multidrug treatment lowers the relative risk for respiratory-related hospitalizations to 0.67.
Timeline
January 1, 2020 - November 30, 2025: Analysis window for real-world claims data.
May 2026: ENCORE trial data presented at the ATS conference.
October 21-24, 2026: IDWeek 2026 conference held in Washington, DC.
January 28, 2027: FDA target action date for the ALIS supplemental application.
The Big Picture
The trial results are currently under the FDA's supplemental new drug application priority review process to determine if the treatment will be approved for broader clinical use.
This development could provide patients with a more effective treatment option that reduces the likelihood of hospitalizations due to severe respiratory issues. Patients should consult their pulmonologists regarding current treatment standards and future medication availability.
The takeaway
The addition of targeted inhaled therapies to standard multidrug regimens shows promise in improving recovery rates for complex lung infections. Patients managing chronic respiratory conditions should prioritize early intervention strategies to reduce the risk of acute exacerbations.
What happens next
The FDA is expected to reach a decision on the supplemental new drug application for the therapy on January 28, 2027.
Further reading
For additional context on pulmonary health research, visit the Asthma section.
Source note: This article includes information reported by Ajmc.
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