Study to Evaluate ALIS (Amikacin Liposome Inhalation Suspension) in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex
Public ClinicalTrials.gov record NCT04677569. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
ENCORE - A Randomized, Double-Blind, Placebo-Controlled, Active Comparator, Multicenter Study to Evaluate the Efficacy and Safety of an Amikacin Liposome Inhalation Suspension (ALIS)-Based Regimen in Adult Subjects With Newly Diagnosed Nontuberculous Mycobacterial (NTM) Lung Infection Caused by Mycobacterium Avium Complex (MAC)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The main objective of this study is to evaluate the efficacy of ALIS (amikacin liposome inhalation suspension) + background regimen (azithromycin \[AZI\] + ethambutol \[ETH\]) compared to the ELC (empty liposome control) + background regimen on participant-reported respiratory symptoms at Month 13.
Study identification
- NCT ID
- NCT04677569
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 425 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 1, 2021 (Actual)
- Primary completion
- Nov 21, 2025 (Actual)
- Completion
- Jan 15, 2026 (Actual)
- Last update posted
- Feb 3, 2026
2021 – 2026
United States locations
- U.S. sites
- 90
- U.S. states
- 28
- U.S. cities
- 74
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| USA008 | Birmingham | Alabama | 35233-1711 | — |
| USA062 | Fresno | California | 93701 | — |
| USA060 | Los Angeles | California | 90033-5313 | — |
| USA090 | Newport Beach | California | 92663 | — |
| USA058 | Sacramento | California | 95817 | — |
| USA048 | San Diego | California | 92103 | — |
| USA081 | San Francisco | California | 94143 | — |
| USA055 | Santa Barbara | California | 93105 | — |
| USA050 | Stanford | California | 94305 | — |
| USA001 | Denver | Colorado | 80206 | — |
| USA023 | Washington D.C. | District of Columbia | 20007 | — |
| USA080 | Bradenton | Florida | 34209 | — |
| USA028 | Brandon | Florida | 33511-5719 | — |
| USA003 | Clearwater | Florida | 33765 | — |
| USA043 | Jacksonville | Florida | 32204 | — |
| USA072 | Jacksonville | Florida | 32207-8567 | — |
| USA085 | Jacksonville | Florida | 32209-6511 | — |
| USA047 | Jacksonville | Florida | 32224 | — |
| USA042 | Kissimmee | Florida | 34746 | — |
| USA019 | Leesburg | Florida | 34748 | — |
| USA039 | Naples | Florida | 34102-5444 | — |
| USA096 | Naples | Florida | 34102 | — |
| USA097 | Naples | Florida | 34102 | — |
| USA046 | New Port Richey | Florida | 34652 | — |
| USA054 | Sarasota | Florida | 34239-2913 | — |
| USA084 | Sebastian | Florida | 32958 | — |
| USA026 | Sebring | Florida | 33870 | — |
| USA070 | St. Petersburg | Florida | 33704-2733 | — |
| USA014 | St. Petersburg | Florida | 33707 | — |
| USA067 | Tampa | Florida | 33606 | — |
| USA068 | Tampa | Florida | 33614-7101 | — |
| USA053 | Weston | Florida | 33331 | — |
| USA038 | Atlanta | Georgia | 30342-2147 | — |
| USA066 | Augusta | Georgia | 30912 | — |
| USA004 | Lawrenceville | Georgia | 30046-3325 | — |
| USA029 | Rincon | Georgia | 31326 | — |
| USA079 | Coeur d'Alene | Idaho | 83814 | — |
| USA031 | Chicago | Illinois | 60611 | — |
| USA073 | Springfield | Illinois | 62702-4968 | — |
| USA030 | Springfield | Illinois | 62702 | — |
| USA074 | Iowa City | Iowa | 52242-1081 | — |
| USA037 | Kansas City | Kansas | 66160 | — |
| USA002 | New Orleans | Louisiana | 70112 | — |
| USA017 | Baltimore | Maryland | 21224-3057 | — |
| USA099 | Lexington | Massachusetts | 02421 | — |
| USA077 | Springfield | Massachusetts | 01107 | — |
| USA013 | Rochester | Minnesota | 55905 | — |
| USA082 | Columbia | Missouri | 65212-1000 | — |
| USA061 | St Louis | Missouri | 63110 | — |
| USA045 | Omaha | Nebraska | 68124 | — |
| USA009 | Omaha | Nebraska | 68198 | — |
| USA069 | Hillsborough | New Jersey | 08844 | — |
| USA032 | Toms River | New Jersey | 08755-8000 | — |
| USA065 | Bayside | New York | 11361 | — |
| USA088 | East Syracuse | New York | 13057 | — |
| USA011 | New York | New York | 10017 | — |
| USA059 | The Bronx | New York | 10461 | — |
| USA076 | Charlotte | North Carolina | 28204 | — |
| USA035 | Charlotte | North Carolina | 28273 | — |
| USA033 | Charlotte | North Carolina | 28277-8915 | — |
| USA051 | Durham | North Carolina | 27710-0001 | — |
| USA034 | Mooresville | North Carolina | 28117 | — |
| USA007 | Winston-Salem | North Carolina | 27103 | — |
| USA075 | Cincinnati | Ohio | 45242-4402 | — |
| USA064 | Cincinnati | Ohio | 45267 | — |
| USA018 | Cleveland | Ohio | 44195 | — |
| USA063 | Columbus | Ohio | 43210-1240 | — |
| USA071 | Portland | Oregon | 97213-2982 | — |
| USA025 | Portland | Oregon | 97239 | — |
| USA015 | DuBois | Pennsylvania | 15801 | — |
| USA040 | Philadelphia | Pennsylvania | 19104 | — |
| USA093 | Philadelphia | Pennsylvania | 19107 | — |
| USA092 | Providence | Rhode Island | 02906 | — |
| USA044 | Anderson | South Carolina | 29621 | — |
| USA024 | Charleston | South Carolina | 29414 | — |
| USA020 | Charleston | South Carolina | 29425 | — |
| USA012 | Rock Hill | South Carolina | 29732 | — |
| USA022 | Franklin | Tennessee | 37067 | — |
| USA041 | Hendersonville | Tennessee | 37075 | — |
| USA078 | Nashville | Tennessee | 37232 | — |
| USA016 | Dallas | Texas | 75246 | — |
| USA100 | Dallas | Texas | 75246 | — |
| USA091 | Denison | Texas | 75020 | — |
| USA086 | Houston | Texas | 77070-1190 | — |
| USA021 | McKinney | Texas | 75069-8085 | — |
| USA006 | San Antonio | Texas | 78258 | — |
| USA089 | Temple | Texas | 76508 | — |
| USA052 | Tyler | Texas | 75708 | — |
| USA083 | Charlottesville | Virginia | 22903 | — |
| USA087 | Madison | Wisconsin | 53792-0001 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 168 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04677569, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 3, 2026 · Synced Oct 23, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04677569 live on ClinicalTrials.gov.