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Controlled-Release Oxycodone vs. Placebo in the Treatment of Chronic Breathlessness—A Multisite Randomized Placebo Controlled Trial

Ferreira, Diana H. ; Louw, Sandra ; McCloud, Philip ; Fazekas, Belinda ; McDonald, Christine F. ; Agar, Meera R. ; Clark, Katherine ; McCaffrey, Nikki ; Ekström, Magnus LU orcid and Currow, David C. (2020) In Journal of Pain and Symptom Management 59(3). p.581-589
Abstract

Context: Chronic breathlessness is a clinical syndrome that results in significant distress and disability. Morphine can reduce chronic breathlessness when the contributing etiologies are optimally treated. Objectives: Does oxycodone reduce chronic breathlessness compared with placebo? Methods: A multisite, randomized, placebo-controlled, double-blind, parallel-arm, fixed-dose trial of oral controlled-release oxycodone 15 mg (5 mg, eight hourly) or placebo (ACTRN12609000806268 at www.anzctr.org.au). As-needed immediate-release morphine (2.5 mg per dose; six and less 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... (More)

Context: Chronic breathlessness is a clinical syndrome that results in significant distress and disability. Morphine can reduce chronic breathlessness when the contributing etiologies are optimally treated. Objectives: Does oxycodone reduce chronic breathlessness compared with placebo? Methods: A multisite, randomized, placebo-controlled, double-blind, parallel-arm, fixed-dose trial of oral controlled-release oxycodone 15 mg (5 mg, eight hourly) or placebo (ACTRN12609000806268 at www.anzctr.org.au). As-needed immediate-release morphine (2.5 mg per dose; six and less 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 naive. The primary end point was the proportion of people with greater than 15% reduction from baseline in the intensity of breathlessness now (0–100 mm visual analogue scale) comparing arms Days 5–7. Secondary end points were average and worst breathlessness, quality of life, function, and harms. Results: Of 157 participants randomized, 155 were included (74 oxycodone and 81 placebo), but the study did not reach target recruitment. There was difference in neither between groups for the primary outcome (P = 0.489) nor any of the prespecified secondary outcomes. Placebo participants used more as-needed morphine (mean 7.0 vs. 4.2 doses; P ≤ 0.001). Oxycodone participants reported more nausea (P < 0.001). Conclusion: 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.

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author collaboration
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
Chronic breathlessness, effectiveness study, oxycodone, palliative care, placebo study, randomized controlled trial, symptom control
in
Journal of Pain and Symptom Management
volume
59
issue
3
pages
9 pages
publisher
Elsevier
external identifiers
  • pmid:31655189
  • scopus:85076852832
ISSN
0885-3924
DOI
10.1016/j.jpainsymman.2019.10.017
language
English
LU publication?
yes
id
b467e79d-e585-41df-a728-8417872a8626
date added to LUP
2020-01-10 13:39:33
date last changed
2024-06-13 09:40:37
@article{b467e79d-e585-41df-a728-8417872a8626,
  abstract     = {{<p>Context: Chronic breathlessness is a clinical syndrome that results in significant distress and disability. Morphine can reduce chronic breathlessness when the contributing etiologies are optimally treated. Objectives: Does oxycodone reduce chronic breathlessness compared with placebo? Methods: A multisite, randomized, placebo-controlled, double-blind, parallel-arm, fixed-dose trial of oral controlled-release oxycodone 15 mg (5 mg, eight hourly) or placebo (ACTRN12609000806268 at www.anzctr.org.au). As-needed immediate-release morphine (2.5 mg per dose; six and less 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 naive. The primary end point was the proportion of people with greater than 15% reduction from baseline in the intensity of breathlessness now (0–100 mm visual analogue scale) comparing arms Days 5–7. Secondary end points were average and worst breathlessness, quality of life, function, and harms. Results: Of 157 participants randomized, 155 were included (74 oxycodone and 81 placebo), but the study did not reach target recruitment. There was difference in neither between groups for the primary outcome (P = 0.489) nor any of the prespecified secondary outcomes. Placebo participants used more as-needed morphine (mean 7.0 vs. 4.2 doses; P ≤ 0.001). Oxycodone participants reported more nausea (P &lt; 0.001). Conclusion: 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.</p>}},
  author       = {{Ferreira, Diana H. and Louw, Sandra and McCloud, Philip and Fazekas, Belinda and McDonald, Christine F. and Agar, Meera R. and Clark, Katherine and McCaffrey, Nikki and Ekström, Magnus and Currow, David C.}},
  issn         = {{0885-3924}},
  keywords     = {{Chronic breathlessness; effectiveness study; oxycodone; palliative care; placebo study; randomized controlled trial; symptom control}},
  language     = {{eng}},
  number       = {{3}},
  pages        = {{581--589}},
  publisher    = {{Elsevier}},
  series       = {{Journal of Pain and Symptom Management}},
  title        = {{Controlled-Release Oxycodone vs. Placebo in the Treatment of Chronic Breathlessness—A Multisite Randomized Placebo Controlled Trial}},
  url          = {{http://dx.doi.org/10.1016/j.jpainsymman.2019.10.017}},
  doi          = {{10.1016/j.jpainsymman.2019.10.017}},
  volume       = {{59}},
  year         = {{2020}},
}