Skip to main content
placeholder image

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)

Journal Article


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).

Publication Date


  • 2020

Published In


Citation


  • Higginson, I. J., Wilcock, A., Johnson, M. J., Bajwah, S., Lovell, N., Yi, D., . . . 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. doi:10.1136/thoraxjnl-2019-213879

Scopus Eid


  • 2-s2.0-85077759661

Start Page


  • 176

End Page


  • 179

Volume


  • 75

Issue


  • 2

Place Of Publication


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).

Publication Date


  • 2020

Published In


Citation


  • Higginson, I. J., Wilcock, A., Johnson, M. J., Bajwah, S., Lovell, N., Yi, D., . . . 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. doi:10.1136/thoraxjnl-2019-213879

Scopus Eid


  • 2-s2.0-85077759661

Start Page


  • 176

End Page


  • 179

Volume


  • 75

Issue


  • 2

Place Of Publication