Study to Evaluate ALIS (Amikacin Liposome Inhalation Suspension) in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex
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Phase
Phase 3
Status
Completed
Study type
Interventional
Design
Randomized · Double · Treatment
Enrollment
425actual
Sites
258
Countries
Argentina, Australia, Austria +20
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2021-04-01 | actual | When the study began enrolling |
| Primary completion | 2025-11-21 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-01-15 | actual | The whole study's end, after follow-up |
| First posted | 2020-12-21 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-02-03 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Mycobacterium Infections, Nontuberculous
Interventions
- Drug: ALIS — also filed as Amikacin liposome inhalation suspension, ARIKAYCE®
- Drug: Azithromycin — also filed as AZI, Zithromax
- Drug: Ethambutol — also filed as ETH, Myambutol
- Drug: ELC (matching placebo for ALIS) — also filed as Empty liposome control
Primary outcome
what the primary-completion date above is the date OFChange from Baseline in Respiratory Symptom Score at Month 13
measured Baseline to Month 13
Publications
- PMID 41100013 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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