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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 protocol

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    Author
    Currow, D; Watts, GJ; Johnson, M; McDonald, CF; Miners, JO; Somogyi, AA; Denehy, L; McCaffrey, N; Eckert, DJ; McCloud, P; ...
    Date
    2017-07-01
    Source Title
    BMJ Open
    Publisher
    BMJ PUBLISHING GROUP
    University of Melbourne Author/s
    Denehy, Linda; McDonald, Christine
    Affiliation
    Medicine and Radiology
    Melbourne School of Health Sciences
    Metadata
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    Document Type
    Journal Article
    Citations
    Currow, D., Watts, G. J., Johnson, M., McDonald, C. F., Miners, J. O., Somogyi, A. A., Denehy, L., McCaffrey, N., Eckert, D. J., McCloud, P., Louw, S., Lam, L., Greene, A., Fazekas, B., Clark, K. C., Fong, K., Agar, M. R., Joshi, R., Kilbreath, S. ,... Ekstrom, M. (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, 7 (7), https://doi.org/10.1136/bmjopen-2017-018100.
    Access Status
    Open Access
    URI
    http://hdl.handle.net/11343/256482
    DOI
    10.1136/bmjopen-2017-018100
    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.

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