Please use this identifier to cite or link to this item: http://hdl.handle.net/2440/110372
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Type: Journal article
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
Author: Currow, D.
Watts, G.
Johnson, M.
McDonald, C.
Miners, J.
Somogyi, A.
Denehy, L.
McCaffrey, N.
Eckert, D.
McCloud, P.
Louw, S.
Lam, L.
Greene, A.
Fazekas, B.
Clark, K.
Fong, K.
Agar, M.
Joshi, R.
Kilbreath, S.
Ferreira, D.
et al.
Citation: BMJ Open, 2017; 7(7):e018100-1-e018100-18
Publisher: BMJ Publishing Group
Issue Date: 2017
ISSN: 2044-6055
2044-6055
Statement of
Responsibility: 
David Currow, Gareth John Watts, Miriam Johnson, Christine F McDonald, John O Miners, Andrew A Somogyi, Linda Denehy, Nicola McCaffrey, Danny J Eckert, Philip McCloud, Sandra Louw, Lawrence Lam, Aine Greene, Belinda Fazekas, Katherine C Clark, Kwun Fong, Meera R Agar, Rohit Joshi, Sharon Kilbreath, Diana Ferreira, Magnus Ekström, on behalf of the Australian national Palliative Care Clinical Studies Collaborative (PaCCSC)
Abstract: 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.
Keywords: Australian national Palliative Care Clinical Studies Collaborative (PaCCSC)
Rights: © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted. This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
RMID: 0030073316
DOI: 10.1136/bmjopen-2017-018100
Grant ID: http://purl.org/au-research/grants/nhmrc/1065571
Appears in Collections:Medicine publications

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