Evidence map›Paper›PMID 31915308›Full record

Trial reportThorax2020

Randomised, double-blind, multicentre, mixed-methods, dose-escalation feasibility trial of mirtazapine for better treatment of severe breathlessness in advanced lung disease (BETTER-B feasibility).

Irene J Higginson, Andrew Wilcock, Miriam J Johnson, Sabrina Bajwah, Natasha Lovell, Deokhee Yi, Simon P Hart, Vincent Crosby, Heather Poad, David Currow and 3 more

Open access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Thorax, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
2.0field-weighted citation impact, top 11% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it, 26 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Review
  4. Article
  5. Review
  6. Review
  7. Article
  8. Article
  9. Article
  10. Review
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

13 authors at 5 institutions in 2 countries.

Irene J HigginsonCicely Saunders Institute of Palliative Care, Policy and Rehabilitation, Kings College London and King's College Hospital NHS Foundation Trust, London, UK irene.higginson@kcl.ac.uk.ORCID 0000-0002-3687-1313
Andrew WilcockDepartment of Clinical Oncology, University of Nottingham and Nottingham University Hospitals NHS Trust, Nottingham, UK.ORCID 0000-0002-3214-1188
Miriam J JohnsonWolfson Palliative Care Research Centre, Hull York Medical School, The University of Hull, Hull, UK.ORCID 0000-0001-6204-9158
Sabrina BajwahCicely Saunders Institute of Palliative Care, Policy and Rehabilitation, Kings College London and King's College Hospital NHS Foundation Trust, London, UK.
Natasha LovellCicely Saunders Institute of Palliative Care, Policy and Rehabilitation, Kings College London and King's College Hospital NHS Foundation Trust, London, UK.
Deokhee YiCicely Saunders Institute of Palliative Care, Policy and Rehabilitation, Kings College London and King's College Hospital NHS Foundation Trust, London, UK.
Simon P HartRespiratory Research Group, Hull York Medical School, University of Hull, Castle Hill Hospital, University of Hull, Hull, Kingston upon Hull, UK.
Vincent CrosbyPalliative Care, Nottingham University Hospitals NHS Trust, Nottingham, UK.
Heather PoadClinical Trials Research Unit (CTRU), University of Leeds, Leeds, West Yorkshire, UK.
David CurrowFaculty of Heath, University of Technology Sydney, Sydney, New South Wales, Australia.ORCID 0000-0003-1988-1250
Emma BestClinical Trials Research Unit (CTRU), University of Leeds, Leeds, West Yorkshire, UK.
Sarah BrownClinical Trials Research Unit (CTRU), University of Leeds, Leeds, West Yorkshire, UK.
BETTER-B Feasibility Trial Group
King's College London · GBUniversity of Leeds · GBNottingham University Hospitals NHS Trust · GBUniversity of Hull · GBUniversity of Technology Sydney · AU

Funding

Marie Curie MCCC-RP-15-A18859
6 · The paper itself

Abstract

New treatments are required for severe breathlessness in advanced disease. We conducted a randomised feasibility trial of mirtazapine over 28 days in adults with a modified medical research council breathlessness scale score ≥3. Sixty-four patients were randomised (409 screened), achieving our primary feasibility endpoint of recruitment. Most patients had COPD or interstitial lung disease; 52 (81%) completed the trial. There were no differences between placebo and mirtazapine in tolerability or safety, and blinding was maintained. Worst breathlessness ratings at day 28 (primary clinical activity endpoint) were, 7.1 (SD 2.3, placebo) and 6.3 (SD 1.8, mirtazapine). A phase III trial of mirtazapine is indicated. Trial registration: ISRCTN 32236160; European Clinical Trials Database (EudraCT no: 2015-004064-11).

Indexed as

Patient SelectionAdministration, OralAdultDose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleDyspneaEuropeFeasibility StudiesFemaleFollow-Up StudiesHumansLung Diseases, InterstitialMaleMaximum Tolerated DoseMiddle AgedMirtazapineCOPD exacerbationsCOPD pharmacologydrug reactionsemphysemaidiopathic pulmonary fibrosislung cancerpalliative carepsychology

Identifiers

PMID31915308
PMCPMC7029228
OpenAlexW2996871075

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.