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Lykfeldt and Wife's Scholarship"},{"DOI":"10.13039\/501100022415","name":"Lillebaelt Hospital","doi-asserted-by":"crossref","id":[{"id":"10.13039\/501100022415","id-type":"DOI","asserted-by":"crossref"}]},{"name":"AP M\u00f8ller Foundation"},{"name":"Eva Merete Falck Crone Foundation"},{"DOI":"10.13039\/501100024075","name":"Region of Southern Denmark","doi-asserted-by":"crossref","id":[{"id":"10.13039\/501100024075","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2026,1,29]]},"published-print":{"date-parts":[[2026,2]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>\n                      Cannabis-based medicine may alleviate breathlessness. This study will investigate whether dronabinol, a synthetic form of \u0394\n                      <jats:sup>9<\/jats:sup>\n                      -tetrahydrocannabinol (\u0394\n                      <jats:sup>9<\/jats:sup>\n                      -THC), reduces breathlessness in patients with severe and very severe chronic obstructive pulmonary disease (sCOPD) compared to placebo.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This single-centre, randomised, double-blinded, placebo-controlled, crossover trial will enrol 30 patients with sCOPD and persistent breathlessness despite optimal treatment. Patients will be recruited from a pulmonary outpatient clinic in Denmark over 24 months. Eligible patients (aged \u226518 years) will receive either dronabinol or placebo for 4\u2009weeks, followed by a 2-week washout, before crossing over to the other treatment for 4\u2009weeks. Exclusion criteria include ongoing infection, substance abuse and significant comorbidities. Primary outcome is breathing discomfort or unpleasantness measured using the 0\u201310 Numerical Rating Scale. Secondary outcomes include lung function (forced expiratory volume in one second), hair cortisol concentrations, functional tests, plasma THC blood concentrations and questionnaires assessing breathlessness, activity, quality of life, anxiety and depression. Continuous monitoring of vital signs, activity and sleep will be performed using a Garmin Venu 3 smartwatch. Data will be entered into electronic case report forms and monitored by the Good Clinical Practice (GCP) unit in Odense.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Discussion<\/jats:title>\n                    <jats:p>This will be the largest randomised, double-blinded, crossover trial to investigate dronabinol in patients with COPD and will provide new knowledge on the efficacy and safety.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>\n                      Written informed consents will be obtained from study patients. The study has been approved by the Danish Medicines Agency (case number: 2023010659) and the medical research ethics committees (case number: 2301456). It is registered in the European Union Clinical Trials Registry (2024-513593-22-00) and ClinicalTrials.gov (\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT06473701\">NCT06473701<\/jats:ext-link>\n                      ). The trial follows the Declaration of Helsinki II and International Council for Harmonisation-GCP guidelines. Findings will be disseminated in peer-reviewed publications.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      The European Union Clinical Trials Registry (2024-513593-22-00) and ClinicalTrials.gov (\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT06473701\">NCT06473701<\/jats:ext-link>\n                      ).\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2025-104957","type":"journal-article","created":{"date-parts":[[2026,2,16]],"date-time":"2026-02-16T14:55:20Z","timestamp":1771253720000},"page":"e104957","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":0,"title":["Reducing severe breathlessness with dronabinol in the group of patients with severe and very severe chronic obstructive pulmonary disease (BONG): a randomised, double-blinded, placebo-controlled, crossover study in an outpatient clinic in Denmark \u2013 a study protocol"],"prefix":"10.1136","volume":"16","clinical-trial-number":[{"clinical-trial-number":"nct06473701","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct06473701","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Sofie Krogh","family":"Wolsing","sequence":"first","affiliation":[{"name":"Department of Medicine, Lillebaelt Hospital\u2014University Hospital of Southern Denmark, Vejle, Denmark"},{"name":"Department of Regional Health Research, University of Southern Denmark, Odense, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ole","family":"Hilberg","sequence":"additional","affiliation":[{"name":"Department of Medicine, Lillebaelt Hospital\u2014University Hospital of Southern Denmark, Vejle, Denmark"},{"name":"Department of Regional Health Research, University of Southern Denmark, Odense, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anders","family":"L\u00f8kke","sequence":"additional","affiliation":[{"name":"Department of Medicine, Lillebaelt Hospital\u2014University Hospital of Southern Denmark, Vejle, Denmark"},{"name":"Department of Regional Health Research, University of Southern Denmark, Odense, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ingeborg","family":"Farver-Vestergaard","sequence":"additional","affiliation":[{"name":"Department of Medicine, Lillebaelt Hospital\u2014University Hospital of Southern Denmark, Vejle, Denmark"},{"name":"Department of Regional Health Research, University of Southern Denmark, Odense, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Charlotte Uggerh\u00f8j","family":"Andersen","sequence":"additional","affiliation":[{"name":"Department of Forensic Medicine, Aarhus University, Aarhus, Denmark"},{"name":"Department of Clinical Pharmacology, Aarhus University Hospital, Aarhus, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9564-958X","authenticated-orcid":false,"given":"Kristina Kock","family":"Hansen","sequence":"additional","affiliation":[{"name":"Department of Medicine, Lillebaelt Hospital\u2014University Hospital of Southern Denmark, Vejle, Denmark"},{"name":"Department of Regional Health Research, University of Southern Denmark, Odense, Denmark"},{"name":"Research Center for Integrated Healthcare, Region of Southern Denmark, Aabenraa, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2026,2,16]]},"reference":[{"key":"2026021609461375000_16.2.e104957.1","doi-asserted-by":"publisher","DOI":"10.1164\/rccm.202301-0106PP"},{"key":"2026021609461375000_16.2.e104957.2","doi-asserted-by":"crossref","first-page":"281","DOI":"10.1016\/j.ejcdt.2012.08.012","article-title":"Quality of life in COPD patients","volume":"61","author":"Zamzam","year":"2012","journal-title":"Egyptian Journal of Chest Diseases and Tuberculosis"},{"key":"2026021609461375000_16.2.e104957.3","doi-asserted-by":"crossref","DOI":"10.1186\/s12931-017-0548-3","article-title":"Understanding the impact of symptoms on the burden of COPD","volume":"18","author":"Miravitlles","year":"2017","journal-title":"Respir Res"},{"key":"2026021609461375000_16.2.e104957.4","unstructured":"Global Initiative for Chronic Obstructive Lung Disease . 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