CONTENTed: the effect of mepolizumab on neuroimaging in severe asthma.
Research type
Research Study
Full title
CONTENTed study: Characterisation Of Neuroimaging and wellbeing over Time in severe EosiNophilic asthma Treated with mepolizumab.
IRAS ID
328150
Contact name
JW Dodd
Contact email
Sponsor organisation
Research and Innovation, North Bristol NHS Trust
Duration of Study in the UK
1 years, 7 months, 4 days
Research summary
There is a high prevalence of anxiety, depression and neurocognitive dysfunction which impacts on the wellbeing of patients with severe asthma. These factors may be the result of poorly controlled asthma, the effects of asthma treatments, but also themselves impact on asthma severity. The relationship between these factors is not well understood.
Magnetic resonance imaging (MRI) of the brain demonstrates structural and functional differences between the brains of people with asthma and those without. Though not extensively studied, a small number group of trials have shown a 'normalisation' of brain activity after cognitive behavioural therapy in patients with asthma and depression. The effect of asthma treatments on brain structure and activity requires further investigation.
Mepolizumab is amongst a group of injectable treatments that have revolutionised the treatment of poorly controlled severe eosinophilic asthma. Randomised controlled trial and real-world data shows reduced exacerbations and oral corticosteroid use in patients taking mepolizumab. Trials also show improved asthma-specific quality of life, though there have not been studies that have assessed anxiety, depression, well-being and cognition in detail.
In this observational study we propose to examine the MRI structure and function of the brains of people with severe eosinophilic asthma before and six months after starting mepolizumab as part of routine clinical practice. We will collect detailed health and neurocognitive information to evaluate changes in psychological health and cognition with mepolizumab. We will compare these data, to results in patients with well-controlled asthma. We will assess whether changes seen on MRI brain imaging relate to the direct effect of the mepolizumab on the brain, or of the secondary effects of improved asthma control that is known to be achieved by mepolizumab.
The study is funded by GlaxoSmithKline, who manufacture mepolizumab, and will be centred in the southwest of England.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
23/EM/0195
Date of REC Opinion
3 Oct 2023
REC opinion
Further Information Favourable Opinion