Evidence map›Paper›PMID 28716797›Full record

Trial reportBMJ open2017

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.

David Currow, Gareth John Watts, Miriam Johnson, Christine F McDonald, John O Miners, Andrew A Somogyi, Linda Denehy, Nicola McCaffrey, Danny J Eckert, Philip McCloud and 12 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIIMulticenter StudyPragmatic Clinical Trial
In one paragraph

Trial report in BMJ open, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02720822 (A Pragmatic, Phase III, Multi-site, Double-blind, Placebo Controlled, Parallel Arm, Dose Increment Randomised Trial of Regular, Low Dose Extended Release Morphine for Chronic Refractory Breathlessness), which is not on this map. Cited by 14 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 2 pooled it
3.3field-weighted citation impact, top 7% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02720822 phase3completednot on this map

A Pragmatic, Phase III, Multi-site, Double-blind, Placebo Controlled, Parallel Arm, Dose Increment Randomised Trial of Regular, Low Dose Extended Release Morphine for Chronic Refractory Breathlessness

TypeinterventionalSponsorFlinders UniversityRan2016 to 2019Enrolled171ConditionsChronic Obstructive Pulmonary Disease, DyspneaArmsPlacebo, Morphine Sulfate, Plus laxative (Docusate with senna), Plus placebo laxative, FitBit charge HR (Accelerometer)
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 2 syntheses or guidelines pooled it, 34 citations in OpenAlex.

  1. Opioids for the palliation of symptoms in people with serious respiratory illness: a systematic review and meta-analysis.European respiratory review : an official journal of the European Respiratory Society · 2024
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

22 authors at 11 institutions in 3 countries.

David CurrowDiscipline, Palliative and Supportive Services, Flinders University, Adelaide, Australia.ORCID http://orcid.org/0000-0003-1988-1250
Gareth John WattsDepartment of Palliative Care, Calvary Mater Newcastle, Newcastle, Australia.
Miriam JohnsonWolfson Palliative Care Research Centre, Hull York Medical School, University of Hull, Hull, UK.
Christine F McDonaldDepartment of Austin Health, Respiratory and Sleep Medicine, Austin Hospital, Heidelberg, Australia.
John O MinersClinical Pharmacology School of Medicine, Flinders University, Adelaide, Australia.
Andrew A SomogyiDepartment of Clinical Pharmacology, Adelaide Medical School, University of Adelaide, Adelaide, Australia.
Linda DenehySchool of Health Sciences, University of Melbourne, Parkville, Victoria, Australia.
Nicola McCaffreyDiscipline, Palliative and Supportive Services, Flinders University, Adelaide, Australia.
Danny J EckertNeuroscience Research Australia (NeRA) Randwick, New South Wales, Australia.
Philip McCloudMCloud Consulting Group, Belrose, New South Wales, Australia.
Sandra LouwMCloud Consulting Group, Belrose, New South Wales, Australia.
Lawrence LamFaculty of Health, University of Technology Sydney, Sydney, Australia.
Aine GreeneSouthern Adelaide Palliative Services, Adelaide, South Australia, Australia.
Belinda FazekasDiscipline, Palliative and Supportive Services, Flinders University, Adelaide, Australia.
Katherine C ClarkDepartment of Palliative Care, Calvary Mater Newcastle, Newcastle, Australia.
Kwun FongThoracic Research Centre, The Prince Charles Hospital School of Medicine, University of Queensland, Australia.
Meera R AgarDiscipline, Palliative and Supportive Services, Flinders University, Adelaide, Australia.
Rohit JoshiDepartment of Medical Oncology, University of Adelaide Lyell MEwin Hospital, Adelaide, Australia.
Sharon KilbreathFaculty of Health, University of Technology Sydney, Sydney, Australia.
Diana FerreiraDiscipline, Palliative and Supportive Services, Flinders University, Adelaide, Australia.
Magnus EkströmDiscipline, Palliative and Supportive Services, Flinders University, Adelaide, Australia.
Australian national Palliative Care Clinical Studies Collaborative (PaCCSC)
Flinders University · AUUniversity of Technology Sydney · AUCalvary Mater Newcastle Hospital · AUAustin Hospital · AULyell McEwin Hospital · AUNeuroscience Research Australia · AUNovita · AUThe University of Adelaide · AUThe University of Melbourne · AUThe University of Queensland · AUUniversity of Hull · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionChronic 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.

Indexed as

AustraliaCost-Benefit AnalysisDelayed-Action PreparationsDouble-Blind MethodDyspneaHumansMorphinePhysical ExertionPulmonary Disease, Chronic ObstructiveRegression AnalysisResearch DesignTreatment OutcomeDelayed-Action PreparationsMorphinechronic breathlessnessopioidspalliative careprotocolrandomised control trial

Identifiers

PMID28716797
PMCPMC5726102
OpenAlexW2735457929

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.