Periodic Reporting for period 1 - BETTER-B (BETTER TREATMENTS FOR BREATHLESSNESS IN PALLIATIVE AND END OF LIFE CARE)
Reporting period: 2019-01-01 to 2020-06-30
In parallel, the setup of the main trial (WP2) is progressing. The protocol and study documents are complete, and translations by each of the EU sites into local languages are being finalised. The draft statistical analysis plan is also being reviewed and finalised. A contract for the IMP supply is in place, with the first batch of IMP available for shipment to sites in August 2020. In the UK, Clinical Trial Authorisation from the Medicines and Healthcare Products Regulatory Agency (MHRA) and ethical approval from the UK Research Ethics Committee (REC) have been obtained. For EU sites, regulatory approval from the Irish Health Products Regulatory Authority is in place, and we are attending Irish REC in early September 2020. We are finalising documents for the German, Italian and Polish regulatory approval and ethics submissions. The BETTER-B project has increased relevance at this time given the COVID-19 pandemic. Breathlessness is a key symptoms of COVID-19 and there is also evidence that some patients develop lung fibrosis post COVID-19 infection. We are expanding one of our inclusion criteria, interstitial lung disease, to include chronic fibrotic lung disease following SARS-CoV-2 infection. We are also amending our protocol to allow for remote consent and follow up of participants who may be shielding from COVID-19 so they can take part in the BETTER-B trial. Substantial amendment requests are in process with the UK MHRA and REC to authorise these changes.
As a result of WP7 BETTER-B is developing a strong public presence. Dissemination efforts are guided by a project stakeholder analysis and dissemination plan focused on raising awareness of the BETTER-B programme, its aims and potential impacts. In the first 18 months we have produced a series of press releases, launched the BETTER-B project website (www.betterbreathe.eu) and shared three project newsletters. For WP8, key tasks are focused on setting up the project structures to successfully oversee, coordinate and manage the project work packages and consortium going forward. In months 1-18, the BETTER-B consortium have produced key project documents including the project handbook, data and risk management plans to support the successful coordination of the BETTER-B project. Four consortium meetings have been held to foster communication across partners and progress deliverables and milestones.
Advances BETTER-B will bring about include:
• Timely testing of a new therapeutic option for a common symptom in palliative and end of life care, with robust data on its effectiveness and cost effectiveness;
• If mirtazapine is found to be effective, the potential to be of benefit to patients with many advanced conditions, and their families. It is available in all European countries at low cost. Equally, if mirtazapine is not cost-effective in patients with breathlessness, the findings will save resources as the results will enable decision makers to recommend that mirtazapine should not routinely be used for this patient group;
• Understanding whether mirtazapine is clinically and cost effective, will help to develop further interventions for breathlessness;
• The health economic components of our study will test methods of measuring cost effectiveness in this group, which will aid future studies, improving care;
• The largest randomised trial on breathlessness in palliative and end of life care in the world to date;
• The potential to merge data with major trials in breathlessness being conducted by members of the consortium. Such a meta-analysis will provide unparalleled understanding of breathlessness and allow better comparisons of potential treatments;
• The development of a European wide collaborative between respiratory and palliative care that will be a platform for future studies
We have assembled a unique collaboration of diverse clinicians, researchers, health professionals and social scientists in five European countries to lead the BETTER-B project. Through our nine work packages, we expect our findings to have the following impacts:
• Reduced symptom burden and suffering or improved well-being of patients in need of palliative, end of life or survivorship care and of their formal and informal caregivers;
• Improved clinical guidance and policy recommendations;
• Improved quality, effectiveness and cost-effectiveness of palliative, end of life or survivorship care services as well as access to care;
• Reduced economic and wider societal burden arising from increased numbers of patients in need of palliative, end of life or survivorship care.