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Please use this identifier to cite or link to this item: https://hdl.handle.net/11055/453
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dc.contributor.authorCurrow, David
dc.contributor.authorWatts, Gareth John
dc.contributor.authorJohnson, Miriam
dc.contributor.authorMcDonald, Christine F
dc.contributor.authorMiners, John O
dc.contributor.authorSomogyi, Andrew A
dc.contributor.authorDenehy, Linda
dc.contributor.authorMcCaffrey, Nicola
dc.contributor.authorEckert, Danny J
dc.contributor.authorMcCloud, Philip
dc.contributor.authorLouw, Sandra
dc.contributor.authorLam, Lawrence
dc.contributor.authorGreene, Aine
dc.contributor.authorFazekas, Belinda
dc.contributor.authorClark, Katherine C
dc.contributor.authorFong, Kwun
dc.contributor.authorAgar, Meera R
dc.contributor.authorJoshi, Rohit
dc.contributor.authorKilbreath, Sharon
dc.contributor.authorFerreira, Diana
dc.contributor.authorEkström, Magnus
dc.date2017
dc.date.accessioned2018-04-08T01:03:16Z-
dc.date.available2018-04-08T01:03:16Z-
dc.date.issued2017-07-17
dc.identifier.citationBMJ open 2017-07-17; 7(7): e018100
dc.identifier.urihttp://hdl.handle.net/11055/453-
dc.description.abstractChronic 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.
dc.language.isoeng
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.journaltitleBMJ open
dc.identifier.orcidhttp://orcid.org/0000-0003-1988-1250
dc.identifier.doi10.1136/bmjopen-2017-018100
dc.description.pubmedurihttps://www.ncbi.nlm.nih.gov/pubmed/28716797
dc.identifier.pubmedid28716797
item.fulltextNo Fulltext-
item.grantfulltextnone-
item.languageiso639-1en-
item.cerifentitytypePublications-
item.openairetypeJournal Article-
item.openairecristypehttp://purl.org/coar/resource_type/c_18cf-
Appears in Collections:Scholarly and Clinical
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