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dc.contributor.authorCurrow, David-
dc.contributor.authorWatts, Gareth John-
dc.contributor.authorJohnson, Miriam-
dc.contributor.authorMcDonald, Christine F-
dc.contributor.authorMiners, John O-
dc.contributor.authorSomogyi, Andrew A-
dc.contributor.authorDenehy, Linda-
dc.contributor.authorMcCaffrey, Nicola-
dc.contributor.authorEckert, Danny J-
dc.contributor.authorMcCloud, Philip-
dc.contributor.authorLouw, Sandra-
dc.contributor.authorLam, Lawrence-
dc.contributor.authorGreene, Aine-
dc.contributor.authorFazekas, Belinda-
dc.contributor.authorClark, Katherine C-
dc.contributor.authorFong, Kwun-
dc.contributor.authorAgar, Meera R-
dc.contributor.authorJoshi, Rohit-
dc.contributor.authorKilbreath, Sharon-
dc.contributor.authorFerreira, Diana-
dc.contributor.authorEkström, Magnus-
dc.identifier.citationBMJ open 2017; 7(7): e018100-
dc.description.abstractChronic breathlessness is highly prevalent and distressing to patients and families. No medication is registered for its symptomatic reduction. The strongest evidence is for regular, low-dose, extended- release (ER) oral morphine. A recent large phase III study suggests the subgroup most likely to benefit have chronic obstructive pulmonary disease (COPD) and modified Medical Research Council breathlessness scores of 3 or 4. This protocol is for an adequately powered, parallel-arm, placebo-controlled, multisite, factorial, block-randomised study evaluating regular ER morphine for chronic breathlessness in people with COPD. The primary question is what effect regular ER morphine has on worst breathlessness, measured daily on a 0-10 numerical rating scale. Uniquely, the coprimary outcome will use a FitBit to measure habitual physical activity. Secondary questions include safety and, whether upward titration after initial benefit delivers greater net symptom reduction. Substudies include longitudinal driving simulation, sleep, caregiver, health economic and pharmacogenetic studies. Seventeen centres will recruit 171 participants from respiratory and palliative care. The study has five phases including three randomisation phases to increasing doses of ER morphine. All participants will receive placebo or active laxatives as appropriate. Appropriate statistical analysis of primary and secondary outcomes will be used. Ethics approval has been obtained. Results of the study will be submitted for publication in peer-reviewed journals, findings presented at relevant conferences and potentially used to inform registration of ER morphine for chronic breathlessness. NCT02720822; Pre-results.-
dc.subjectchronic breathlessness-
dc.subjectpalliative care-
dc.subjectrandomised control trial-
dc.titleA pragmatic, phase III, multisite, double-blind, placebo-controlled, parallel-arm, dose increment randomised trial of regular, low-dose extended-release morphine for chronic breathlessness: Breathlessness, Exertion And Morphine Sulfate (BEAMS) study protocol.-
dc.typeClinical Trial, Phase III-
dc.typeJournal Article-
dc.typeMulticenter Study-
dc.typePragmatic Clinical Trial-
dc.identifier.journaltitleBMJ open-
dc.identifier.affiliationDiscipline, Palliative and Supportive Services, Flinders University, Adelaide, Australia-
dc.identifier.affiliationDepartment of Palliative Care, Calvary Mater Newcastle, Newcastle, Australia-
dc.identifier.affiliationWolfson Palliative Care Research Centre, Hull York Medical School, University of Hull, Hull, UK-
dc.identifier.affiliationHull York Medical School, University of Hull, Hull, UK-
dc.identifier.affiliationDepartment of, Respiratory and Sleep Medicine, Austin Health, Heidelberg, Victoria, Australia-
dc.identifier.affiliationClinical Pharmacology School of Medicine, Flinders University, Adelaide, Australia-
dc.identifier.affiliationDepartment of Clinical Pharmacology, Adelaide Medical School, University of Adelaide, Adelaide, Australia-
dc.identifier.affiliationSchool of Health Sciences, University of Melbourne, Parkville, Victoria, Australia-
dc.identifier.affiliationNeuroscience Research Australia (NeRA) Randwick, New South Wales, Australia-
dc.identifier.affiliationMCloud Consulting Group, Belrose, New South Wales, Australia-
dc.identifier.affiliationSouthern Adelaide Palliative Services, Adelaide, South Australia, Australia-
dc.identifier.affiliationSchool of Medicine and Public Health, The University of Newcastle, Newcastle, New South Wales, Australia-
dc.identifier.affiliationThoracic Research Centre, The Prince Charles Hospital School of Medicine, University of Queensland, Australia-
dc.identifier.affiliationFaculty of Health, University of Technology Sydney, Sydney, Australia-
dc.identifier.affiliationClinical Trials, Ingham Institute of Applied Medical Research, Sydney, Australia-
dc.identifier.affiliationSouth West Sydney Clinical School, University of New South Wales, Sydney, Australia-
dc.identifier.affiliationDepartment of Medical Oncology, University of Adelaide Lyell MEwin Hospital, Adelaide, Australia-
dc.identifier.affiliationDepartment of Respiratory Medicine and Allergology, Institution for Clinical Sciences, Lund University, Sweden-
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