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dc.contributor.authorCurrow, D
dc.contributor.authorWatts, GJ
dc.contributor.authorJohnson, M
dc.contributor.authorMcDonald, CF
dc.contributor.authorMiners, JO
dc.contributor.authorSomogyi, AA
dc.contributor.authorDenehy, L
dc.contributor.authorMcCaffrey, N
dc.contributor.authorEckert, DJ
dc.contributor.authorMcCloud, P
dc.contributor.authorLouw, S
dc.contributor.authorLam, L
dc.contributor.authorGreene, A
dc.contributor.authorFazekas, B
dc.contributor.authorClark, KC
dc.contributor.authorFong, K
dc.contributor.authorAgar, MR
dc.contributor.authorJoshi, R
dc.contributor.authorKilbreath, S
dc.contributor.authorFerreira, D
dc.contributor.authorEkstrom, M
dc.date.accessioned2020-12-21T01:22:26Z
dc.date.available2020-12-21T01:22:26Z
dc.date.issued2017-07-01
dc.identifierpii: bmjopen-2017-018100
dc.identifier.citationCurrow, 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.
dc.identifier.issn2044-6055
dc.identifier.urihttp://hdl.handle.net/11343/256482
dc.description.abstractINTRODUCTION: 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.
dc.languageEnglish
dc.publisherBMJ PUBLISHING GROUP
dc.titleA 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
dc.typeJournal Article
dc.identifier.doi10.1136/bmjopen-2017-018100
melbourne.affiliation.departmentMedicine and Radiology
melbourne.affiliation.departmentMelbourne School of Health Sciences
melbourne.source.titleBMJ Open
melbourne.source.volume7
melbourne.source.issue7
dc.rights.licenseCC BY-NC
melbourne.elementsid1224313
melbourne.contributor.authorDenehy, Linda
melbourne.contributor.authorMcDonald, Christine
dc.identifier.eissn2044-6055
melbourne.accessrightsOpen Access


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