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Title: Controlled-release oxycodone versus placebo in the treatment of chronic breathlessness - a multi-site randomised placebo controlled trial.
Austin Authors: Ferreira, Diana H;Louw, Sandra;McCloud, Philip;Fazekas, Belinda;McDonald, Christine F ;Agar, Meera;Clark, Katherine;McCaffrey, Nikki;Ekström, Magnus;Currow, David C
Affiliation: Lund University, Faculty of Medicine, Department of Clinical Sciences Lund, Respiratory Medicine and Allergology, Lund, Sweden
University of Sydney, Glebe, New South Wales. Australia
IMPACCT, Faculty of Health, University of Technology Sydney, Ultimo, New South Wales. Australia
Deakin Health Economics, School of Health and Social Development, Deakin University, Victoria, Australia
IMPACCT, Faculty of Health, University of Technology Sydney, Ultimo, New South Wales. Australia
Austin Health, Heidelberg, Victoria, Australia
University of Melbourne, Parkville, Victoria. Australia
McCloud Consulting Group, Narabang Way, Belrose, New South Wales, Australia
Discipline, Palliative and Supportive Services, Flinders University, Adelaide, South Australia, Australia
Northern Sydney Local Health District, St Leonards, New South Wales, Australia
Issue Date: 23-Oct-2019 2019-10-23
Publication information: Journal of pain and symptom management 2019; online first: 23 October
Abstract: Chronic breathlessness is a clinical syndrome that results in significant distress and disability. Morphine can reduce chronic breathlessness when the contributing aetiologies are optimally treated. Does oxycodone reduce chronic breathlessness compared with placebo? A multi-site, randomised, placebo-controlled, double-blind, parallel-arm, fixed-dose trial of oral controlled-release oxycodone 15mg (5 mg 8 hourly) or placebo (ACTRN12609000806268 at 'As needed' immediate-release morphine (2.5mg per dose; ≤6 doses/day) was available for both arms as required by one ethics committee overseeing the trial.Recruitment occurred from 2010 to 2014 in 14 inpatient and outpatient respiratory, cardiology and palliative care services across Australia. Participants were adults, with chronic breathlessness (modified Medical Research Council Scale 3 or 4), who were opioid naïve. The primary endpoint was the proportion of people with >15% reduction from baseline in the intensity of breathlessness now (0-100 mm visual analogue scale) comparing arms days 5-7. Secondary endpoints were 'average' and 'worst' breathlessness; quality of life; function; and harms. Of 157 participants randomised, 155 were included (74 oxycodone, 81 placebo), but the study did not reach target recruitment. There was no difference between groups for the primary outcome (p=0.489) nor any of the pre-specified secondary outcomes. Placebo participants used more 'as needed' morphine (mean 7.0 versus 4.2 doses; p≤0.001). Oxycodone participants reported more nausea (p<0.001). There was no signal of benefit from oxycodone over placebo. Future research should focus on investigating the existence of an opioid class effect on the reduction of chronic breathlessness.
DOI: 10.1016/j.jpainsymman.2019.10.017
ORCID: 0000-0001-6481-3391
PubMed URL: 31655189
Type: Journal Article
Subjects: Chronic breathlessness
effectiveness study
palliative care
placebo study
randomised controlled trial
symptom control
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