BETTER-B(Feasibility): BETter TreatmEnts for Refractory Breathlessness
Research type
Research Study
Full title
BETTER-B (Feasibility): BETter TreatmEnts for Refractory Breathlessness: a feasibility study of the use of mirtazapine for refractory breathlessness
IRAS ID
187894
Contact name
Jackie Pullen
Contact email
Sponsor organisation
King's College London
Eudract number
2015-004064-11
Duration of Study in the UK
2 years, 0 months, 0 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.
This study is a feasibility trial and if it is successful, we hope to run a much larger trial in the future. We will find out two things:
• are the trial methods and the drug acceptable to those participating and can we recruit enough people to the study?
• 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 28 days and will be assessed by the study research team over the phone and in person every 7 days during trial treatment and then 7 days after taking the last study drug dose.
REC name
London - Central Research Ethics Committee
REC reference
16/LO/0091
Date of REC Opinion
29 Jan 2016
REC opinion
Favourable Opinion