RT Journal Article
SR Electronic
T1 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
JF BMJ Open
JO BMJ Open
FD British Medical Journal Publishing Group
SP e018100
DO 10.1136/bmjopen-2017-018100
VO 7
IS 7
A1 David Currow
A1 Gareth John Watts
A1 Miriam Johnson
A1 Christine F McDonald
A1 John O Miners
A1 Andrew A Somogyi
A1 Linda Denehy
A1 Nicola McCaffrey
A1 Danny J Eckert
A1 Philip McCloud
A1 Sandra Louw
A1 Lawrence Lam
A1 Aine Greene
A1 Belinda Fazekas
A1 Katherine C Clark
A1 Kwun Fong
A1 Meera R Agar
A1 Rohit Joshi
A1 Sharon Kilbreath
A1 Diana Ferreira
A1 Magnus Ekström
A1 ,
YR 2017
UL http://bmjopen.bmj.com/content/7/7/e018100.abstract
AB 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.