{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T19:01:10Z","timestamp":1790794870299,"version":"4.1.0"},"reference-count":0,"publisher":"Oxford University Press (OUP)","license":[{"start":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T00:00:00Z","timestamp":1790726400000},"content-version":"am","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Rationale<\/jats:title>\n                    <jats:p>Current recommended front-line multidrug therapy (MDT) for Mycobacterium avium complex lung disease (MACLD) produces suboptimal outcomes. Amikacin liposome inhalation suspension (ALIS) with MDT is approved for refractory MACLD; however, clinical trial evidence in newly diagnosed MACLD is lacking.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>To evaluate efficacy and safety of ALIS with MDT in the phase 3b, randomized, double-blind, placebo-controlled superiority trial in adults newly diagnosed with MACLD who have not initiated antibiotics (ENCORE NCT04677569).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Patients (N\u2009=\u2009425) were randomized 1:1 to receive ALIS 590\u2009mg (n\u2009=\u2009213) or placebo (n\u2009=\u2009212) plus azithromycin 250\u2009mg and ethambutol 15\u2009mg\/kg once daily for 12 months. Primary endpoint was change from baseline to month 13 in Respiratory Symptom Score (RSS). Pre-specified secondary endpoints included culture conversion (CC) at clinically important timepoints, durable culture conversion (DCC), and safety.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Median age was 68.0 years, 62.8% were White, and 79.3% were female. Significantly greater improvements in RSS were observed in the ALIS versus comparator arm at 1 month post-treatment (month 13; LS mean change: 17.77 vs 14.66 points; treatment difference 3.11 points; P=0.0299), with improvements sustained at 3 months post-treatment (month 15; treatment arm difference 4.80 points; nominal P=0.0015). Significantly greater proportions of patients achieved CC by month 13 and DCC at month 15 in the ALIS arm versus comparator arm (82.4% vs 55.6% and 76.2% vs 47.6%, respectively; both P&amp;lt;0.0001). No new safety signals were observed.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>ALIS with MDT was superior to the comparator arm for improving respiratory symptoms and CC in patients newly diagnosed with MACLD.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/ajrccm\/aamag530","type":"journal-article","created":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T12:03:22Z","timestamp":1790769802000},"source":"Crossref","is-referenced-by-count":0,"title":["Amikacin Liposome Inhalation Suspension in Newly Diagnosed\n                    <i>Mycobacterium avium<\/i>\n                    Complex Lung Disease: A Phase 3b, Double-blind, Randomized Clinical Trial (ENCORE)"],"prefix":"10.1093","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3324-926X","authenticated-orcid":false,"given":"Charles L","family":"Daley","sequence":"first","affiliation":[{"name":"National Jewish Health and the University of Colorado School of Medicine Division of Mycobacterial and Respiratory Diseases, , Denver, Colorado,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8239-9275","authenticated-orcid":false,"given":"Kozo","family":"Morimoto","sequence":"additional","affiliation":[{"name":"Fukuj\u016bji Hospital, Japan Anti-Tuberculosis Association Department of Clinical Research, , Tokyo,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0686-171X","authenticated-orcid":false,"given":"Rachel","family":"Thomson","sequence":"additional","affiliation":[{"name":"Greenslopes Private Hospital Gallipoli Medical Research, , Greenslopes, Queensland,","place":["Australia"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7242-0747","authenticated-orcid":false,"given":"Eva","family":"Van Braeckel","sequence":"additional","affiliation":[{"name":"Ghent University Hospital Department of Respiratory Medicine, , Ghent,","place":["Belgium"]},{"name":"Ghent University Department of Internal Medicine and Pediatrics, Faculty of Medicine and Health Sciences, , Ghent,","place":["Belgium"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0717-7450","authenticated-orcid":false,"given":"Naoki","family":"Hasegawa","sequence":"additional","affiliation":[{"name":"Keio University School of Medicine Department of Infectious Diseases, , Tokyo,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David E","family":"Griffith","sequence":"additional","affiliation":[{"name":"National Jewish Health and the University of Colorado School of Medicine Division of Mycobacterial and Respiratory Diseases, , Denver, Colorado,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1560-6879","authenticated-orcid":false,"given":"Patrick A","family":"Flume","sequence":"additional","affiliation":[{"name":"Medical University of South Carolina Department of Medicine and Pediatrics, , Charleston, South Carolina,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5514-7868","authenticated-orcid":false,"given":"James D","family":"Chalmers","sequence":"additional","affiliation":[{"name":"University of Oxford Radcliffe Department of Medicine, , Oxford,","place":["UK"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kevin L","family":"Winthrop","sequence":"additional","affiliation":[{"name":"Oregon Health & Science University , Portland, Oregon,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5965-9913","authenticated-orcid":false,"given":"Michael R","family":"Loebinger","sequence":"additional","affiliation":[{"name":"Royal Brompton Hospital and NHLI, Imperial College London , London,","place":["UK"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel","family":"Serrano","sequence":"additional","affiliation":[{"name":"The Psychometrics Team , Sheridan, Wyoming,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0581-2003","authenticated-orcid":false,"given":"Jakko","family":"van Ingen","sequence":"additional","affiliation":[{"name":"Radboud University Medical Center Department of Medical Microbiology, Radboudumc Community for Infectious Diseases, , Nijmegen, the","place":["Netherlands"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dayton W","family":"Yuen","sequence":"additional","affiliation":[{"name":"Insmed Incorporated , Bridgewater, New Jersey,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mariam","family":"Hassan","sequence":"additional","affiliation":[{"name":"Insmed Incorporated , Bridgewater, New Jersey,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pan","family":"Wu","sequence":"additional","affiliation":[{"name":"Insmed Incorporated , Bridgewater, New Jersey,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marie-Laure","family":"Nevoret","sequence":"additional","affiliation":[{"name":"Insmed Incorporated , Bridgewater, New Jersey,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kevin","family":"Mange","sequence":"additional","affiliation":[{"name":"Insmed Incorporated , Bridgewater, New Jersey,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anne E","family":"O\u2019Donnell","sequence":"additional","affiliation":[{"name":"Medstar Georgetown University Hospital Division of Pulmonary, Critical Care and Sleep Medicine, Georgetown University Medical Center\/ , Washington DC,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"ENCORE Study Group","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2026,9,30]]},"container-title":["American Journal of Respiratory and Critical Care Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/ajrccm\/advance-article-pdf\/doi\/10.1093\/ajrccm\/aamag530\/71531824\/aamag530.pdf","content-type":"application\/pdf","content-version":"am","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/ajrccm\/advance-article-pdf\/doi\/10.1093\/ajrccm\/aamag530\/71531824\/aamag530.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T18:41:25Z","timestamp":1790793685000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/ajrccm\/advance-article\/doi\/10.1093\/ajrccm\/aamag530\/8855653"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,9,30]]},"references-count":0,"URL":"https:\/\/doi.org\/10.1093\/ajrccm\/aamag530","relation":{},"ISSN":["1073-449X","1535-4970"],"issn-type":[{"value":"1073-449X","type":"print"},{"value":"1535-4970","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,9,30]]},"article-number":"aamag530"}}