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).

• 影响指数: 9.102
• 发表时间: 02 2020
• 来源期刊: Thorax
• DOI: 10.1136/thoraxjnl-2019-213879
• PMID: 31915308
• 文章类型: Journal Article
• 中科院分区: Q1
• 方向: 医学
• 作者列表: Higginson IJ,Wilcock A,Johnson MJ,Bajwah S,Lovell N,Yi D,Hart SP,Crosby V,Poad H,Currow D,Best E,Brown S,

关键词: COPD exacerbations; COPD pharmacology; drug reactions; emphysema; idiopathic pulmonary fibrosis; lung cancer; palliative care; psychology

Mesh: Administration, Oral; Adult; Dose-Response Relationship, Drug; Double-Blind Method; Drug Administration Schedule; Dyspnea / diagnosis drug therapy; Europe; Feasibility Studies; Female; Follow-Up Studies; Humans; Lung Diseases, Interstitial / diagnosis drug therapy mortality; Male; Maximum Tolerated Dose; Middle Aged; Mirtazapine / therapeutic use; Patient Selection; Pulmonary Disease, Chronic Obstructive / diagnosis drug therapy mortality; Severity of Illness Index; Treatment Outcome

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).