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; Emma Best; Sarah Brown; BETTER-B Feasibility Trial Group

doi:10.1136/thoraxjnl-2019-213879

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
, Emma Best
, Sarah Brown
, BETTER-B Feasibility Trial Group

Research output: Contribution to journal › Article › peer-review

18 Citations (Scopus)

77 Downloads (Pure)

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).

Original language	English
Pages (from-to)	176-179
Number of pages	4
Journal	Thorax
Volume	75
Issue number	2
DOIs	https://doi.org/10.1136/thoraxjnl-2019-213879
Publication status	Published - Feb 2020
Externally published	Yes

Bibliographical note

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

Keywords

COPD exacerbations
COPD pharmacology
drug reactions
emphysema
idiopathic pulmonary fibrosis
lung cancer
palliative care
psychology

Access to Document

10.1136/thoraxjnl-2019-213879Licence: CC BY

Published versionFinal published version, 1.02 MBLicence: CC BY

Cite this

Higginson, I. J., Wilcock, A., Johnson, M. J., Bajwah, S., Lovell, N., Yi, D., Hart, S. P., Crosby, V., Poad, H., Currow, D., Best, E., Brown, S., & BETTER-B Feasibility Trial Group (2020). 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). Thorax, 75(2), 176-179. https://doi.org/10.1136/thoraxjnl-2019-213879

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title = "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)",

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).",

keywords = "COPD exacerbations, COPD pharmacology, drug reactions, emphysema, idiopathic pulmonary fibrosis, lung cancer, palliative care, psychology",

author = "Higginson, \{Irene J.\} and Andrew Wilcock and Johnson, \{Miriam J.\} and Sabrina Bajwah and Natasha Lovell and Deokhee Yi and Hart, \{Simon P.\} and Vincent Crosby and Heather Poad and David Currow and Emma Best and Sarah Brown and \{BETTER-B Feasibility Trial Group\} and Jackie Pullen and Katie Neville and Victoria Hiley and Vicky Liversedge and Avie-Lee Tillotson and M Paine",

note = "This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.",

year = "2020",

month = feb,

doi = "10.1136/thoraxjnl-2019-213879",

language = "English",

volume = "75",

pages = "176--179",

journal = "Thorax",

issn = "0040-6376",

publisher = "BMJ Publishing Group",

number = "2",

}

Higginson, IJ, Wilcock, A, Johnson, MJ, Bajwah, S, Lovell, N, Yi, D, Hart, SP, Crosby, V, Poad, H, Currow, D, Best, E, Brown, S & BETTER-B Feasibility Trial Group 2020, '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)', Thorax, vol. 75, no. 2, pp. 176-179. https://doi.org/10.1136/thoraxjnl-2019-213879

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). / Higginson, Irene J.; Wilcock, Andrew; Johnson, Miriam J. et al.
In: Thorax, Vol. 75, No. 2, 02.2020, p. 176-179.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - 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)

AU - Higginson, Irene J.

AU - Wilcock, Andrew

AU - Johnson, Miriam J.

AU - Bajwah, Sabrina

AU - Lovell, Natasha

AU - Yi, Deokhee

AU - Hart, Simon P.

AU - Crosby, Vincent

AU - Poad, Heather

AU - Currow, David

AU - Best, Emma

AU - Brown, Sarah

AU - BETTER-B Feasibility Trial Group

AU - Pullen, Jackie

AU - Neville, Katie

AU - Hiley, Victoria

AU - Liversedge, Vicky

AU - Tillotson, Avie-Lee

AU - Paine, M

N1 - This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

PY - 2020/2

Y1 - 2020/2

N2 - 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).

AB - 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).

KW - COPD exacerbations

KW - COPD pharmacology

KW - drug reactions

KW - emphysema

KW - idiopathic pulmonary fibrosis

KW - lung cancer

KW - palliative care

KW - psychology

UR - https://www.scopus.com/pages/publications/85077759661

U2 - 10.1136/thoraxjnl-2019-213879

DO - 10.1136/thoraxjnl-2019-213879

M3 - Article

C2 - 31915308

AN - SCOPUS:85077759661

SN - 0040-6376

VL - 75

SP - 176

EP - 179

JO - Thorax

JF - Thorax

IS - 2

ER -

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)

Abstract

Bibliographical note

UN SDGs

Keywords

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