Descrizione del progetto
Verso un miglior trattamento della dispnea refrattaria
La dispnea cronica è una terribile malattia associata a morbilità fisiche e psicosociali. Essendo poche le terapie farmacologiche in grado di trattarla efficacemente, questa malattia provoca gravi disagi per i pazienti affetti e le loro famiglie. Il progetto BETTER-B, finanziato dall’UE, sta verificando la possibilità di utilizzare la mirtazapina, un antidepressivo consolidato, per trattare la dispnea cronica, come suggerito da un recente studio di fattibilità. I ricercatori di BETTER-B condurranno una sperimentazione clinica randomizzata in doppio cieco al fine di mettere alla prova l’efficacia e la convenienza economica della mirtazapina rispetto al placebo in pazienti situati in diversi paesi europei. Il progetto comprende inoltre un’indagine online effettuata da medici, la produzione di una guida a livello europeo sulla gestione della dispnea nelle cure palliative e di fine vita e interviste qualitative con i partecipanti alla sperimentazione per comprendere le esperienze trascorse.
Obiettivo
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.
Campo scientifico
Parole chiave
Programma(i)
Argomento(i)
Invito a presentare proposte
Vedi altri progetti per questo bandoBando secondario
H2020-SC1-2018-Single-Stage-RTD
Meccanismo di finanziamento
RIA - Research and Innovation actionCoordinatore
WC2R 2LS London
Regno Unito