BETTER-B Phase 3 Trial
Research type
Research Study
Full title
BETTER-B: BETter TreatmEnts for Refractory Breathlessness. An International, Multicentre, Randomised Controlled Pragmatic Trial of Mirtazapine to alleviate Breathlessness in Palliative and End of Life Care.
IRAS ID
264831
Contact name
Irene Higginson
Contact email
Sponsor organisation
King's College London
Eudract number
2019-002001-21
ISRCTN Number
ISRCTN10487976
Duration of Study in the UK
2 years, 6 months, 1 days
Research summary
Breathlessness is a common symptom affecting 50-70% of people with cancer and over 90% of people with non-cancer lung disease. Even when all the causes for breathlessness are treated, breathlessness often continues; when this happens it is called “refractory” breathlessness. This is very distressing, causes fear and panic, reduces quality of life, including social life, and can result in emergency hospital admissions. At the moment, there is no standard treatment for refractory breathlessness.
In this study we are testing a commonly used antidepressant drug called mirtazapine. It affects a brain chemical called serotonin, which is active when people are breathless. Reports involving small numbers of patients suggest that mirtazapine may help breathlessness. It also might help because it reduces panic. Mirtazapine is used commonly in the UK to treat depression and anxiety. We will aim to find out how effective might mirtazapine be in treating breathlessness.
In this study mirtazapine is being compared to “dummy-drug” known as a placebo. Participants will be given capsules of the study drug, or dummy drug, to take every day for 56 days and will be assessed by the study research team over the phone and in person during trial treatment. Participants lay caregivers will also be invited to take part to provide their assessment and experiences of the participants breathlessness.
REC name
London - London Bridge Research Ethics Committee
REC reference
20/LO/0369
Date of REC Opinion
15 May 2020
REC opinion
Further Information Favourable Opinion