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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 ( IF 9.0 ) Pub Date : 2020-01-08 , DOI: 10.1136/thoraxjnl-2019-213879
Irene J Higginson 1 , Andrew Wilcock 2 , Miriam J Johnson 3 , Sabrina Bajwah 4 , Natasha Lovell 4 , Deokhee Yi 4 , Simon P Hart 5 , Vincent Crosby 6 , Heather Poad 7 , David Currow 8 , Emma Best 7 , Sarah Brown 7 ,
Affiliation  

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).

中文翻译:

米氮平用于改善晚期肺疾病严重呼吸困难的随机,双盲,多中心,混合方法,剂量递增的可行性试验(BETTER-B可行性)。

晚期疾病中严重的呼吸困难需要新的治疗方法。我们对改良的医学研究委员会呼吸困难量表评分≥3的成年人进行了米氮平28天的随机可行性试验。64名患者被随机分组​​(筛查409名),达到了我们招募的主要可行性终点。大多数患者患有COPD或间质性肺疾病;52(81%)完成了审判。安慰剂和米氮平之间在耐受性或安全性方面没有差异,并且维持了致盲性。第28天(主要临床活动终点)的最差呼吸困难等级是7.1(标准差2.3,安慰剂)和6.3(标准差1.8,米氮平)。指示了米氮平的III期试验。试用注册:ISRCTN 32236160;欧洲临床试验数据库(EudraCT no:2015-004064-11)。
更新日期:2020-01-29
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