RCT Abstract - Mirtazapine to alleviate severe breathlessness in patients with COPD or ILD: an international, multicentre, double-blind, randomised, placebo-controlled, phase 3 mixed-method trial (BETTER-B).

<bold>Background:</bold> Breathlessness frequently becomes severe among people with respiratory disease. Mirtazapine, a widely used antidepressant, showed promise. We determined the effectiveness of mirtazapine to alleviate severe persisting breathlessness. <bold>Methods:</bold> This international, multicentre, phase 3, parallel-group, double-blind, randomised, placebo-controlled trial across 16 centres in seven countries, recruited adults with COPD and/ ILD, grade 3 or 4 of the mMRC breathlessness scale. Participants were randomly assigned (1:1) to receive orally mirtazapine or matching placebo for 56 days. Participants, caregivers, assessors, and investigators were masked to group assignment. The primary outcome was ‘worst breathlessness’, at 56 days post treatment start, follow-up to 180 days. Primary analysis was modified intention-to-treat. Findings We enrolled 225 eligible participants (113 mirtazapine, 112 placebo). There was no evidence of difference in ‘worst breathlessness’ at day 56 between groups (difference in adjusted mean NRS score 0·105, 95% CI: −0·407, 0·618, p=0·69). There were 215 and 116 adverse reactions, across 72 (64%) and 44 (40%) participants; 11 and 8 serious adverse events reported on 6 (5%) and 7 (6%) participants receiving mirtazapine and placebo respectively; 1 (1%) suspected unexpected serious adverse reaction for a participant receiving mirtazapine. Interpretation Mirtazapine of doses 15-45mg daily over 56 days does not improve severe breathlessness among patients with COPD or ILD and might cause adverse reactions. It is not recommended to alleviate severe breathlessness.

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Publication Details

Published
2024-09-14
DOI
https://doi.org/10.1183/13993003.congress-2024.rct3721
Primary Topic
Chronic Obstructive Pulmonary Disease (COPD) Research
Type
article
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article

RCT Abstract - Mirtazapine to alleviate severe breathlessness in patients with COPD or ILD: an international, multicentre, double-blind, randomised, placebo-controlled, phase 3 mixed-method trial (BETTER-B).

Sabrina Bajwah, Claudia Bausewein, Peter May, David C. Currow et al.
Chronic Obstructive Pulmonary Disease (COPD) Research
article

RCT Abstract - Mirtazapine to alleviate severe breathlessness in patients with COPD or ILD: an international, multicentre, double-blind, randomised, placebo-controlled, phase 3 mixed-method trial (BETTER-B).

Sabrina Bajwah, Claudia Bausewein, Peter May, David C. Currow, Matthew M Maddocks, Simon P. Hart, Piotr Janowiak, Andrew Wilcock, Caroline J. Jolley, Silvia Tanzi, Julia Brown, Charles Normand, Massimo Costantini, Małgorzata Krajnik, H M Mather, Charlotte E. Bolton, Elena Turola, Steffen T. Simon, Luca Ghirotto, Miriam J. Johnson, Bobbie Farsides, Adejoke O Oluyase, Geraldine Murden, Irene J Higginson, Karen Ryan, Sarah T Brown
article en

Abstract

<bold>Background:</bold> Breathlessness frequently becomes severe among people with respiratory disease. Mirtazapine, a widely used antidepressant, showed promise. We determined the effectiveness of mirtazapine to alleviate severe persisting breathlessness. <bold>Methods:</bold> This international, multicentre, phase 3, parallel-group, double-blind, randomised, placebo-controlled trial across 16 centres in seven countries, recruited adults with COPD and/ ILD, grade 3 or 4 of the mMRC breathlessness scale. Participants were randomly assigned (1:1) to receive orally mirtazapine or matching placebo for 56 days. Participants, caregivers, assessors, and investigators were masked to group assignment. The primary outcome was ‘worst breathlessness’, at 56 days post treatment start, follow-up to 180 days. Primary analysis was modified intention-to-treat. Findings We enrolled 225 eligible participants (113 mirtazapine, 112 placebo). There was no evidence of difference in ‘worst breathlessness’ at day 56 between groups (difference in adjusted mean NRS score 0·105, 95% CI: −0·407, 0·618, p=0·69). There were 215 and 116 adverse reactions, across 72 (64%) and 44 (40%) participants; 11 and 8 serious adverse events reported on 6 (5%) and 7 (6%) participants receiving mirtazapine and placebo respectively; 1 (1%) suspected unexpected serious adverse reaction for a participant receiving mirtazapine. Interpretation Mirtazapine of doses 15-45mg daily over 56 days does not improve severe breathlessness among patients with COPD or ILD and might cause adverse reactions. It is not recommended to alleviate severe breathlessness.

Brighton and Sussex Medical School (GB), University of Leeds (GB), Nottingham University Hospitals NHS Trust (GB), King's College London (GB), University of Wollongong (AU), Mater Misericordiae University Hospital (IE), Nicolaus Copernicus University (PL), Leeds Trinity University (GB), Düsseldorf University Hospital (DE), Azienda Sanitaria Unità Locale di Reggio Emilia (IT), Integrated Oncology (United States) (US), Cicely Saunders International (GB), Nottingham Biomedical Research Centre (GB), University Hospital Cologne (DE), Heinrich Heine University Düsseldorf (DE), Hull York Medical School (GB), Gdańsk Medical University (PL), Ludwig-Maximilians-Universität München (DE)
Openalex Percentile: Top 62%
Chronic Obstructive Pulmonary Disease (COPD) Research
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