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

Higginson IJ; Higginson, Irene; Wilcock, Andrew; Johnson, Miriam; Bajwah, Sabrina; Currow, David; Lovell, Natasha; Yi, Deokhee; Hart, Simon; Crosby, Vincent; Poad, Heather; Best, Emma; Brown, Sarah; Currow DC Best E, Brown SR; Wilcock A; Johnson M; Bajwah S; Lovell N; Yi D; Hart SP; Crosby V; Poad H; Currow DC; Best E; Brown SR

Authors

Higginson IJ

Irene Higginson

Andrew Wilcock

Sabrina Bajwah

David Currow

Natasha Lovell

Deokhee Yi

Simon Hart

Vincent Crosby

Heather Poad

Emma Best

Sarah Brown

Brown SR Currow DC Best E

Wilcock A

Johnson M

Bajwah S

Lovell N

Yi D

Crosby V

Poad H

Best E

Brown SR



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).

Journal Article Type Article
Publication Date Jan 8, 2020
Journal Thorax
Print ISSN 0040-6376
Electronic ISSN 1468-3296
Publisher BMJ Publishing Group
Peer Reviewed Peer Reviewed
APA6 Citation Higginson, I., Wilcock, A., Johnson, M., Bajwah, S., Currow, D., Lovell, N., …Brown, S. (2020). Randomised, double-blind, multi-centre, mixed-methods, dose-escalation feasibility trial of mirtazapine for better treatment of severe breathlessness in advanced lung disease (BETTER-B Feasibility). Thorax, https://doi.org/10.1136/thoraxjnl-2019-213879
DOI https://doi.org/10.1136/thoraxjnl-2019-213879
Keywords COPD Exacerbations; Emphysema; Lung Cancer, Palliative Care; Psychology; COPD Pharmacology; Drug reactions; Idiopathic pulmonary fibrosis

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Copyright Statement
© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ





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