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, D; Watts, GJ; Johnson, M; McDonald, CF; Miners, JO; Somogyi, AA; Denehy, L; McCaffrey, N; Eckert, DJ; McCloud, P; Louw, S; Lam, L; Greene, A; Fazekas, B; Clark, KC; Fong, K; Agar, MR; Joshi, R; Kilbreath, S; Ferreira, D; Ekström, M

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, D

Watts, GJ Johnson, M McDonald, CF Miners, JO Somogyi, AA Denehy, L McCaffrey, N Eckert, DJ McCloud, P Louw, S Lam, L

Greene, A Fazekas, B Clark, KC Fong, K Agar, MR

Joshi, R Kilbreath, S Ferreira, D Ekström, M

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Publication Type:: Journal Article
Citation:: BMJ Open, 2017, 7 (7)
Issue Date:: 2017-07-01

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Field	Value	Language
dc.contributor.author	Currow, D https://orcid.org/0000-0003-1988-1250	en_US
dc.contributor.author	Watts, GJ	en_US
dc.contributor.author	Johnson, M	en_US
dc.contributor.author	McDonald, CF	en_US
dc.contributor.author	Miners, JO	en_US
dc.contributor.author	Somogyi, AA	en_US
dc.contributor.author	Denehy, L	en_US
dc.contributor.author	McCaffrey, N	en_US
dc.contributor.author	Eckert, DJ	en_US
dc.contributor.author	McCloud, P	en_US
dc.contributor.author	Louw, S	en_US
dc.contributor.author	Lam, L https://orcid.org/0000-0001-6183-6854	en_US
dc.contributor.author	Greene, A	en_US
dc.contributor.author	Fazekas, B	en_US
dc.contributor.author	Clark, KC	en_US
dc.contributor.author	Fong, K	en_US
dc.contributor.author	Agar, MR https://orcid.org/0000-0002-6756-6119	en_US
dc.contributor.author	Joshi, R	en_US
dc.contributor.author	Kilbreath, S	en_US
dc.contributor.author	Ferreira, D	en_US
dc.contributor.author	Ekström, M	en_US
dc.date.issued	2017-07-01	en_US
dc.identifier.citation	BMJ Open, 2017, 7 (7)	en_US
dc.identifier.uri	http://hdl.handle.net/10453/112870
dc.description.abstract	© Article author(s). 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.	en_US
dc.relation.ispartof	BMJ Open	en_US
dc.relation.isbasedon	10.1136/bmjopen-2017-018100	en_US
dc.subject.mesh	Humans	en_US
dc.subject.mesh	Pulmonary Disease, Chronic Obstructive	en_US
dc.subject.mesh	Dyspnea	en_US
dc.subject.mesh	Morphine	en_US
dc.subject.mesh	Delayed-Action Preparations	en_US
dc.subject.mesh	Treatment Outcome	en_US
dc.subject.mesh	Regression Analysis	en_US
dc.subject.mesh	Double-Blind Method	en_US
dc.subject.mesh	Research Design	en_US
dc.subject.mesh	Cost-Benefit Analysis	en_US
dc.subject.mesh	Australia	en_US
dc.subject.mesh	Physical Exertion	en_US
dc.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	en_US
dc.type	Journal Article
utslib.citation.volume	7	en_US
utslib.for	1117 Public Health and Health Services	en_US
utslib.for	1103 Clinical Sciences	en_US
utslib.for	1199 Other Medical and Health Sciences	en_US
pubs.embargo.period	Not known	en_US
pubs.organisational-group	/University of Technology Sydney
pubs.organisational-group	/University of Technology Sydney/Faculty of Health
pubs.organisational-group	/University of Technology Sydney/Faculty of Health/IMPACCT
pubs.organisational-group	/University of Technology Sydney/Strength - CHSP - Health Services and Practice
utslib.copyright.status	open_access
pubs.issue	7	en_US
pubs.publication-status	Published	en_US
pubs.volume	7	en_US

Abstract:

© Article author(s). 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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http://hdl.handle.net/10453/112870