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

Research output: Contribution to journalArticlepeer-review

10 Citations (Scopus)

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 languageEnglish
Pages (from-to)176-179
Number of pages4
JournalThorax
Volume75
Issue number2
DOIs
Publication statusPublished - Feb 2020

Keywords

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

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