Project description
Towards improved treatment for refractory breathlessness
Chronic breathlessness (CB) is a frightening disease associated with physical and psychosocial morbidities. Since there are few effective drug treatments, CB causes severe patient and family distress. The EU-funded BETTER-B project is testing whether mirtazapine, an established antidepressant, could be used to treat CB as suggested by a recent feasibility study. BETTER-B researchers will conduct a randomised double-blind clinical trial to test the effectiveness and cost-effectiveness of mirtazapine versus placebo in patients in different European countries. The project also includes an online survey of physicians, production of Europe-wide guidance on breathlessness management in palliative and end-of-life care, and qualitative interviews with trial participants to understand their experiences.
Objective
The BETTER-B consortium tests whether mirtazapine, currently used as an antidepressant, is an effective treatment to reduce chronic or refractory breathlessness (CB) in patients with advanced chronic obstructive pulmonary or interstitial lung disease (COPD or ILD) needing palliative care or at the end of life.
Our focus is on breathlessness that persists despite optimal treatment of the underlying condition. This widespread and frightening symptom has a major detrimental impact on patients’ quality of life and distresses their family, friends and carers. It is associated with physical and psychosocial morbidity and results in high use of health care services, including emergency care.
There are no licenced medicines for CB in the world. It is a major challenge to clinical management, care quality and patient wellbeing. We have completed a feasibility trial in 60 patients, reviews and case studies that suggest mirtazapine is a promising treatment.
To assess if mirtazapine is effective, we conduct a randomised double blind clinical trial of mirtazapine versus placebo in patients with CB and COPD or ILD. The trial recruits 324 patients over 18 months across respiratory, palliative care and community services in Poland, Ireland, Italy, Germany and the UK. We study the effects of treatment over time on patients, their family or caregivers and care costs. We survey clinicians and produce accessible European guidance on treating CB.
The consortium unites a unique multi-disciplinary group of clinician scientists from respiratory, palliative, geriatric and rehabilitation fields, alongside statisticians, trialists, health economists, health care researchers, patient and consumer groups and a European Society. This ensures the optimal design and operation of the trial and the widest impact from its results.
Using an existing medicine for a different purpose offers a highly cost-effective approach for treatment that can be implemented and sustained internationally.
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Funding Scheme
RIA - Research and Innovation actionCoordinator
WC2R 2LS London
United Kingdom