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 HigginsonAndrew WilcockMiriam J JohnsonSabrina BajwahNatasha LovellDeokhee YiSimon P HartVincent CrosbyHeather PoadDavid Christopher CurrowEmma BestSarah Brownnull nullPublished in: Thorax (2020)
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).
Keyphrases
- phase iii
- open label
- clinical trial
- double blind
- placebo controlled
- study protocol
- phase ii
- end stage renal disease
- ejection fraction
- interstitial lung disease
- chronic kidney disease
- newly diagnosed
- randomized controlled trial
- prognostic factors
- emergency department
- early onset
- healthcare
- systemic sclerosis
- cystic fibrosis