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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.
Authors: Currow, David
Watts, Gareth John
Johnson, Miriam
McDonald, Christine F
Miners, John O
Somogyi, Andrew A
Denehy, Linda
McCaffrey, Nicola
Eckert, Danny J
McCloud, Philip
Louw, Sandra
Lam, Lawrence
Greene, Aine
Fazekas, Belinda
Clark, Katherine C
Fong, Kwun
Agar, Meera R
Joshi, Rohit
Kilbreath, Sharon
Ferreira, Diana
Ekström, Magnus
Issue Date: 17-Jul-2017
Source: BMJ open 2017-07-17; 7(7): e018100
Abstract: 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. 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 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. NCT02720822; Pre-results.
DOI: 10.1136/bmjopen-2017-018100
PubMed URL:
Journal Title: BMJ open
Type: Journal Article
Appears in Collections:Scholarly and Clinical

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