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

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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

Currow, David (author): Flinders University,Hull York Medical School

Watts, Gareth John (author): Calvary Mater Newcastle

Johnson, Miriam (author): Hull York Medical School

McDonald, Christine F. (author): Austin Hospital

Miners, John O. (author): Flinders University

Somogyi, Andrew A (author): University of Adelaide

Denehy, Linda (author): University of Melbourne

McCaffrey, Nicola (author): Flinders University

Eckert, Danny J. (author): Neuroscience Research Australia (NeuRA)

McCloud, Philip (author): McCloud Consulting Group

Louw, Sandra (author)

Lam, Lawrence (author): University of Technology Sydney

Greene, Aine (author)

Fazekas, Belinda (author): Flinders University

Clark, Katherine C. (author)

Fong, Kwun (author): University of Queensland

Agar, Meera R. (author): University of Technology Sydney,University of New South Wales,Flinders University

Joshi, Rohit (author): University of Adelaide

Kilbreath, Sharon (author): University of Technology Sydney

Ferreira, Diana (author): Flinders University

Ekström, Magnus (author): Lund University,Lunds universitet,Lungmedicin, allergologi och palliativ medicin,Sektion II,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Andfåddhet och kronisk andningssvikt,Forskargrupper vid Lunds universitet,Respiratory Medicine, Allergology, and Palliative Medicine,Section II,Department of Clinical Sciences, Lund,Faculty of Medicine,Breathlessness and chronic respiratory failure,Lund University Research Groups,Flinders University

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2017-07-17
2017
English.
In: BMJ Open. - : BMJ. - 2044-6055. ; 7:7

Related links:: http://dx.doi.org/10... (free); show more...; https://bmjopen.bmj....; https://lup.lub.lu.s...; https://doi.org/10.1...; show less...

Journal article (peer-reviewed)

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Introduction 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. Methods and analysis 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 and dissemination 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. Trial registration number NCT02720822; Pre-results.

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MEDICAL AND HEALTH SCIENCES: MEDICAL AND HEAL ...; and Clinical Medicin ...; and Respiratory Medi ...

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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

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