{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,2]],"date-time":"2026-10-02T02:39:15Z","timestamp":1790908755416,"version":"4.1.0"},"reference-count":56,"publisher":"BMJ","issue":"1","license":[{"start":{"date-parts":[[2024,5,7]],"date-time":"2024-05-07T00:00:00Z","timestamp":1715040000000},"content-version":"unspecified","delay-in-days":6,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100005627","name":"Thrasher Research Fund","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100005627","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100011302","name":"Children's Hospital Foundation","doi-asserted-by":"publisher","award":["50310"],"award-info":[{"award-number":["50310"]}],"id":[{"id":"10.13039\/100011302","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100000925","name":"NHMRC","doi-asserted-by":"crossref","award":["1154302"],"award-info":[{"award-number":["1154302"]}],"id":[{"id":"10.13039\/501100000925","id-type":"DOI","asserted-by":"crossref"}]},{"DOI":"10.13039\/501100000925","name":"NHMRC","doi-asserted-by":"crossref","award":["1170958"],"award-info":[{"award-number":["1170958"]}],"id":[{"id":"10.13039\/501100000925","id-type":"DOI","asserted-by":"crossref"}]},{"DOI":"10.13039\/501100000925","name":"NHMRC","doi-asserted-by":"crossref","award":["1193796"],"award-info":[{"award-number":["1193796"]}],"id":[{"id":"10.13039\/501100000925","id-type":"DOI","asserted-by":"crossref"}]},{"DOI":"10.13039\/501100000925","name":"NHMRC","doi-asserted-by":"crossref","award":["2025379"],"award-info":[{"award-number":["2025379"]}],"id":[{"id":"10.13039\/501100000925","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open Resp Res"],"accepted":{"date-parts":[[2024,4,19]]},"published-print":{"date-parts":[[2024,5]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Bronchiectasis is a worldwide chronic lung disorder where exacerbations are common. It affects people of all ages, but especially Indigenous populations in high-income nations. Despite being a major contributor to chronic lung disease, there are no licensed therapies for bronchiectasis and there remain relatively few randomised controlled trials (RCTs) conducted in children and adults. Our RCT will address some of these unmet needs by evaluating whether the novel mucoactive agent, erdosteine, has a therapeutic role in children and adults with bronchiectasis.<\/jats:p>\n                    <jats:p>Our primary aim is to determine in children and adults aged 2\u201349 years with bronchiectasis whether regular erdosteine over a 12-month period reduces acute respiratory exacerbations compared with placebo. Our primary hypothesis is that people with bronchiectasis who regularly use erdosteine will have fewer exacerbations than those receiving placebo.<\/jats:p>\n                    <jats:p>Our secondary aims are to determine the effect of the trial medications on quality of life (QoL) and other clinical outcomes (exacerbation duration, time-to-next exacerbation, hospitalisations, lung function, adverse events). We will also assess the cost-effectiveness of the intervention.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>We are undertaking an international multicentre, double-blind, placebo-RCT to evaluate whether 12\u2009months of erdosteine is beneficial for children and adults with bronchiectasis. We will recruit 194 children and adults with bronchiectasis to a parallel, superiority RCT at eight sites across Australia, Malaysia and Philippines. Our primary endpoint is the rate of exacerbations over 12\u2009months. Our main secondary outcomes are QoL, exacerbation duration, time-to-next exacerbation, hospitalisations and lung function.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>The Human Research Ethics Committees (HREC) of Children\u2019s Health Queensland (for all Australian sites), University of Malaya Medical Centre (Malaysia) and St. Luke\u2019s Medical Centre (Philippines) approved the study. We will publish the results and share the outcomes with the academic and medical community, funding and relevant patient organisations.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>ACTRN12621000315819.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjresp-2023-002216","type":"journal-article","created":{"date-parts":[[2024,5,8]],"date-time":"2024-05-08T08:59:05Z","timestamp":1715158745000},"page":"e002216","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":8,"title":["Erdosteine in children and adults with bronchiectasis (BETTER trial): study protocol for a multicentre, double-blind, randomised controlled trial"],"prefix":"10.1136","volume":"11","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1331-3706","authenticated-orcid":false,"given":"Anne B","family":"Chang","sequence":"first","affiliation":[{"name":"Department of Respiratory Medicine, Queensland Children's Hospital, South Brisbane, Queensland, Australia"},{"name":"The Australian Centre for Health Services Innovation (AusHSI), Queensland University of Technology, Brisbane, Queensland, Australia"},{"name":"Child and Maternal Health Division and andand NHMRC Centre for Research Excellence in Paediatric Bronchiectasis (AusBREATHE), Menzies School of Health Research, Darwin, Northern Territory, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephanie T","family":"Yerkovich","sequence":"additional","affiliation":[{"name":"The Australian Centre for Health Services Innovation (AusHSI), Queensland University of Technology, Brisbane, Queensland, Australia"},{"name":"Child and Maternal Health Division and andand NHMRC Centre for Research Excellence in Paediatric Bronchiectasis (AusBREATHE), Menzies School of Health Research, Darwin, Northern Territory, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katherine J","family":"Baines","sequence":"additional","affiliation":[{"name":"School of Medicine and Public Health, The University of Newcastle, Newcastle, New South Wales, Australia"},{"name":"Immune Health Research Program, Hunter Medical Research Institute, Newcastle, New South Wales, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lucy","family":"Burr","sequence":"additional","affiliation":[{"name":"Mater Health Services, South Brisbane, Queensland, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anita","family":"Champion","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, Queensland Children\u2019s Hospital, Brisbane, Queensland, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark D","family":"Chatfield","sequence":"additional","affiliation":[{"name":"The University of Queensland, Brisbane, Queensland, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kah P","family":"Eg","sequence":"additional","affiliation":[{"name":"Department of Paediatrics, Universiti Malaya Faculty of Medicine, Kuala Lumpur, Malaysia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vikas","family":"Goyal","sequence":"additional","affiliation":[{"name":"The Australian Centre for Health Services Innovation (AusHSI), Queensland University of Technology, Brisbane, Queensland, Australia"},{"name":"Department of Paediatrics, Gold Coast Health, Gold Coast, Queensland, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robyn L","family":"Marsh","sequence":"additional","affiliation":[{"name":"Child and Maternal Health Division and andand NHMRC Centre for Research Excellence in Paediatric Bronchiectasis (AusBREATHE), Menzies School of Health Research, Darwin, Northern Territory, Australia"},{"name":"School of Health Sciences, University of Tasmania, Launceston, Tasmania, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gabrielle B","family":"McCallum","sequence":"additional","affiliation":[{"name":"Child and Maternal Health Division and andand NHMRC Centre for Research Excellence in Paediatric Bronchiectasis (AusBREATHE), Menzies School of Health Research, Darwin, Northern Territory, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9078-2357","authenticated-orcid":false,"given":"Margaret","family":"McElrea","sequence":"additional","affiliation":[{"name":"The Australian Centre for Health Services Innovation (AusHSI), Queensland University of Technology, Brisbane, Queensland, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Steven","family":"McPhail","sequence":"additional","affiliation":[{"name":"The Australian Centre for Health Services Innovation (AusHSI), Queensland University of Technology, Brisbane, Queensland, Australia"},{"name":"School of Public Health and Social Work, Faculty of Health, Queensland University of Technology, Australian Centre for Health Services Innovation and Centre for Healthcare Transformation, Brisbane, Queensland, Australia"},{"name":"Metro South Health, Clinical Informatics Directorate, Woollongabba, Queensland, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lucy C","family":"Morgan","sequence":"additional","affiliation":[{"name":"Department of Respiratory Medicine, Concord Repatriation General Hospital, Concord, New South Wales, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter S","family":"Morris","sequence":"additional","affiliation":[{"name":"Child and Maternal Health Division and andand NHMRC Centre for Research Excellence in Paediatric Bronchiectasis (AusBREATHE), Menzies School of Health Research, Darwin, Northern Territory, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anne M","family":"Nathan","sequence":"additional","affiliation":[{"name":"Department of Paediatrics, Universiti Malaya Faculty of Medicine, Kuala Lumpur, Malaysia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hannah","family":"O\u2019Farrell","sequence":"additional","affiliation":[{"name":"The Australian Centre for Health Services Innovation (AusHSI), Queensland University of Technology, Brisbane, Queensland, Australia"},{"name":"Child and Maternal Health Division and andand NHMRC Centre for Research Excellence in Paediatric Bronchiectasis (AusBREATHE), Menzies School of Health Research, Darwin, Northern Territory, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marion O","family":"Sanchez","sequence":"additional","affiliation":[{"name":"Section of Pediatric Pulmonology, Institute of Pulmonary Medicine, St. Luke's Medical Center, Quezon City, 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