Modified-release morphine or placebo for chronic breathlessness: the MABEL trial protocol.

Date, K; Williams, B; Cohen, J; Chaudhuri, N; Bajwah, S; Pearson, M; Higginson, I; Norrie, J; Keerie, C; Tuck, S; Hall, P; Currow, D; Fallon, M; Johnson, M

Modified-release morphine or placebo for chronic breathlessness: the MABEL trial protocol.

Date, K Williams, B Cohen, J Chaudhuri, N Bajwah, S Pearson, M Higginson, I Norrie, J Keerie, C Tuck, S Hall, P Currow, D

Fallon, M Johnson, M

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Publisher:: European Respiratory Society (ERS)
Publication Type:: Journal Article
Citation:: ERJ Open Res, 2023, 9, (4), pp. 167-2023
Issue Date:: 2023-07

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Field	Value	Language
dc.contributor.author	Date, K
dc.contributor.author	Williams, B
dc.contributor.author	Cohen, J
dc.contributor.author	Chaudhuri, N
dc.contributor.author	Bajwah, S
dc.contributor.author	Pearson, M
dc.contributor.author	Higginson, I
dc.contributor.author	Norrie, J
dc.contributor.author	Keerie, C
dc.contributor.author	Tuck, S
dc.contributor.author	Hall, P
dc.contributor.author	Currow, D https://orcid.org/0000-0003-1988-1250
dc.contributor.author	Fallon, M
dc.contributor.author	Johnson, M
dc.date.accessioned	2023-09-20T05:37:17Z
dc.date.available	2023-05-13
dc.date.available	2023-09-20T05:37:17Z
dc.date.issued	2023-07
dc.identifier.citation	ERJ Open Res, 2023, 9, (4), pp. 167-2023
dc.identifier.issn	2312-0541
dc.identifier.issn	2312-0541
dc.identifier.uri	http://hdl.handle.net/10453/172226
dc.description.abstract	Chronic breathlessness, a persistent and disabling symptom despite optimal treatment of underlying causes, is a frightening symptom with serious and widespread impact on patients and their carers. Clinical guidelines support the use of morphine for the relief of chronic breathlessness in common long-term conditions, but questions remain around clinical effectiveness, safety and longer term (>7 days) administration. This trial will evaluate the effectiveness of low-dose oral modified-release morphine in chronic breathlessness. This is a multicentre, parallel group, double-blind, randomised, placebo-controlled trial. Participants (n=158) will be opioid-naïve with chronic breathlessness due to heart or lung disease, cancer or post-coronavirus disease 2019. Participants will be randomised 1:1 to 5 mg oral modified-release morphine/placebo twice daily and docusate/placebo 100 mg twice daily for 56 days. Non-responders at Day 7 will dose escalate to 10 mg morphine/placebo twice daily at Day 15. The primary end-point (Day 28) measure will be worst breathlessness severity (previous 24 h). Secondary outcome measures include worst cough, distress, pain, functional status, physical activity, quality of life, and early identification and management of morphine-related side-effects. At Day 56, participants may opt to take open-label, oral modified-release morphine as part of usual care and complete quarterly breathlessness and toxicity questionnaires. The study is powered to be able to reject the null hypothesis and an embedded normalisation process theory-informed qualitative substudy will explore the adoption of morphine as a first-line pharmacological treatment for chronic breathlessness in clinical practice if effective.
dc.format	Electronic-eCollection
dc.language	eng
dc.publisher	European Respiratory Society (ERS)
dc.relation.ispartof	ERJ Open Res
dc.relation.isbasedon	10.1183/23120541.00167-2023
dc.rights	info:eu-repo/semantics/openAccess
dc.subject.classification	3201 Cardiovascular medicine and haematology
dc.subject.classification	3211 Oncology and carcinogenesis
dc.title	Modified-release morphine or placebo for chronic breathlessness: the MABEL trial protocol.
dc.type	Journal Article
utslib.citation.volume	9
utslib.location.activity	England
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
utslib.copyright.status	open_access	*
dc.date.updated	2023-09-20T05:37:14Z
pubs.issue	4
pubs.publication-status	Published online
pubs.volume	9
utslib.citation.issue	4

Abstract:

Chronic breathlessness, a persistent and disabling symptom despite optimal treatment of underlying causes, is a frightening symptom with serious and widespread impact on patients and their carers. Clinical guidelines support the use of morphine for the relief of chronic breathlessness in common long-term conditions, but questions remain around clinical effectiveness, safety and longer term (>7 days) administration. This trial will evaluate the effectiveness of low-dose oral modified-release morphine in chronic breathlessness. This is a multicentre, parallel group, double-blind, randomised, placebo-controlled trial. Participants (n=158) will be opioid-naïve with chronic breathlessness due to heart or lung disease, cancer or post-coronavirus disease 2019. Participants will be randomised 1:1 to 5 mg oral modified-release morphine/placebo twice daily and docusate/placebo 100 mg twice daily for 56 days. Non-responders at Day 7 will dose escalate to 10 mg morphine/placebo twice daily at Day 15. The primary end-point (Day 28) measure will be worst breathlessness severity (previous 24 h). Secondary outcome measures include worst cough, distress, pain, functional status, physical activity, quality of life, and early identification and management of morphine-related side-effects. At Day 56, participants may opt to take open-label, oral modified-release morphine as part of usual care and complete quarterly breathlessness and toxicity questionnaires. The study is powered to be able to reject the null hypothesis and an embedded normalisation process theory-informed qualitative substudy will explore the adoption of morphine as a first-line pharmacological treatment for chronic breathlessness in clinical practice if effective.

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http://hdl.handle.net/10453/172226