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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 proto

Currow, David, Watts, Gareth John, Johnson, Miriam, McDonald, Christine F., Miners, John O., Somogyi, Andrew A., Denehy, Linda, McCaffrey, Nicola, Eckert, Danny J., McCloud, Phillip, Louw, Sandra, Lam, Lawrence, Greene, Aine, Fazekas, Belinda, Clark, Katherine C., Fong, Kwun, Agar, Meera R., Joshi, Rohit, Kilbreath, Sharon, Ferreira, Diana, Ekström, Magnus and Australian national Palliative Care Clinical Studies Collaborative (PaCCSC) 2017, 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, BMJ open, vol. 7, no. 7, doi: 10.1136/bmjopen-2017-018100.

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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(s) Currow, David
Watts, Gareth John
Johnson, Miriam
McDonald, Christine F.
Miners, John O.
Somogyi, Andrew A.
Denehy, Linda
McCaffrey, NicolaORCID iD for McCaffrey, Nicola orcid.org/0000-0003-3684-3723
Eckert, Danny J.
McCloud, Phillip
Louw, Sandra
Lam, Lawrence
Greene, Aine
Fazekas, Belinda
Clark, Katherine C.
Fong, Kwun
Agar, Meera R.
Joshi, Rohit
Kilbreath, Sharon
Ferreira, Diana
Ekström, Magnus
Australian national Palliative Care Clinical Studies Collaborative (PaCCSC)
Journal name BMJ open
Volume number 7
Issue number 7
Article ID e018100
Total pages 18
Publisher BMJ Open
Place of publication London, Eng.
Publication date 2017-07-17
ISSN 2044-6055
Keyword(s) chronic breathlessness
opioids
palliative care
protocol
randomised control trial
Australian national Palliative Care Clinical Studies Collaborative (PaCCSC)
Summary 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.
Language eng
DOI 10.1136/bmjopen-2017-018100
Field of Research 110399 Clinical Sciences not elsewhere classified
HERDC Research category C1.1 Refereed article in a scholarly journal
ERA Research output type C Journal article
Copyright notice ©2017, the Authors
Free to Read? Yes
Use Rights Creative Commons Attribution non-commercial licence
Persistent URL http://hdl.handle.net/10536/DRO/DU:30105118

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Every reasonable effort has been made to ensure that permission has been obtained for items included in DRO. If you believe that your rights have been infringed by this repository, please contact drosupport@deakin.edu.au.