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; Wilcock, Andrew; Johnson, Miriam J.; Bajwah, Sabrina; Lovell, Natasha; Yi, Deokhee; Hart, Simon; Crosby, Vincent; Poad, Heather; Currow, David; Best, Emma; Brown, Sarah

Abstract

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

Citation

Higginson, I., Wilcock, A., Johnson, M. J., Bajwah, S., Lovell, N., Yi, D., Hart, S., Crosby, V., Poad, H., Currow, D., Best, E., & Brown, S. (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

• Journal Article Type: Article
• Acceptance Date: Nov 18, 2019
• Online Publication Date: Jan 8, 2020
• Publication Date: Feb 1, 2020
• Deposit Date: Nov 28, 2019
• Publicly Available Date: Jan 20, 2020
• Journal: Thorax
• Print ISSN: 0040-6376
• Publisher: BMJ Publishing Group
• Peer Reviewed: Peer Reviewed
• Volume: 75
• Issue: 2
• Pages: 176-179
• 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
• Public URL: https://hull-repository.worktribe.com/output/3267036
• Contract Date: Jan 20, 2020