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Title: A 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.
Austin Authors: Currow, David;Watts, Gareth John;Johnson, Miriam;McDonald, Christine F ;Miners, John O;Somogyi, Andrew A;Denehy, Linda;McCaffrey, Nicola;Eckert, Danny J;McCloud, Philip;Louw, Sandra;Lam, Lawrence;Greene, Aine;Fazekas, Belinda;Clark, Katherine C;Fong, Kwun;Agar, Meera R;Joshi, Rohit;Kilbreath, Sharon;Ferreira, Diana;Ekström, Magnus
Affiliation: Discipline, Palliative and Supportive Services, Flinders University, Adelaide, Australia
Department of Palliative Care, Calvary Mater Newcastle, Newcastle, Australia
Wolfson Palliative Care Research Centre, Hull York Medical School, University of Hull, Hull, UK
Hull York Medical School, University of Hull, Hull, UK
Department of, Respiratory and Sleep Medicine, Austin Health, Heidelberg, Victoria, Australia
Clinical Pharmacology School of Medicine, Flinders University, Adelaide, Australia
Department of Clinical Pharmacology, Adelaide Medical School, University of Adelaide, Adelaide, Australia
School of Health Sciences, University of Melbourne, Parkville, Victoria, Australia
Neuroscience Research Australia (NeRA) Randwick, New South Wales, Australia
MCloud Consulting Group, Belrose, New South Wales, Australia
Southern Adelaide Palliative Services, Adelaide, South Australia, Australia
School of Medicine and Public Health, The University of Newcastle, Newcastle, New South Wales, Australia
Thoracic Research Centre, The Prince Charles Hospital School of Medicine, University of Queensland, Australia
Faculty of Health, University of Technology Sydney, Sydney, Australia
Clinical Trials, Ingham Institute of Applied Medical Research, Sydney, Australia
South West Sydney Clinical School, University of New South Wales, Sydney, Australia
Department of Medical Oncology, University of Adelaide Lyell MEwin Hospital, Adelaide, Australia
Department of Respiratory Medicine and Allergology, Institution for Clinical Sciences, Lund University, Sweden
Issue Date: 17-Jul-2017 2017-07-17
Publication information: BMJ Open 2017; 7(7): e018100
Abstract: Chronic 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.
DOI: 10.1136/bmjopen-2017-018100
ORCID: 0000-0003-1988-1250
PubMed URL: 28716797
Type: Journal Article
Subjects: chronic breathlessness
palliative care
randomised control trial
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