Severe Asthma, MepolizumaB and Affect: SAMBA study

  • Research type

    Research Study

  • Full title

    The biopsychosocial impact of mepolizumab in severe eosinophilic asthma on quantitative and qualitative emotional and affective outcomes in patients and partners

  • IRAS ID

    290856

  • Contact name

    Judit Varkonyi-Sepp

  • Contact email

    j.varkonyi-sepp@soton.ac.uk

  • Sponsor organisation

    University Hospital Southampton NHS Foundation Trust

  • Clinicaltrials.gov Identifier

    NCT04680611

  • Duration of Study in the UK

    3 years, 0 months, 0 days

  • Research summary

    People living with severe asthma have anxiety and depression more often than the average population and also more often than people with less severe asthma. In one of our previous studies, patients with severe asthma had 30% more depressive and 26% more anxiety scores than those with mild asthma (measured on the Hospital Anxiety and Depression Scale). In a subsequent study we found that living with asthma affects both patients and partners, with impact on their emotional state and on how they experience asthma symptoms. In another, qualitative study the very few patients who received mepolizumab reported rapid improvement in their asthma and quality of life after starting this treatment. Their partners also reported marked improvement in their own quality of life. Considering the links between asthma control, emotional states, quality of life and the relationship of these processes between patients and partners, in the current study we aim to gain a better understanding of these interactions in a larger longitudinal observational study. We first will recruit 30 patients who already receive mepolizumab to make sure that our questionnaires detect changes. This we will know by comparing participants’ data with results from a previous study where we collected data using these questionnaires from patients who had severe asthma but were not treated by mepolizumab. We then will collect data from patients who newly receive mepolizumab and also from their partners, first before patients start the treatment and then at 6 months and 12 months in treatment. We will also take blood from patients to assess whether particular inflammatory blood markers are present in particular emotional states as recent research evidence suggest this might be the case. With a subset of the participating couples we will conduct interviews to explore their experiences and the impact of the treatment on their lives. \n

  • REC name

    North West - Liverpool Central Research Ethics Committee

  • REC reference

    21/NW/0054

  • Date of REC Opinion

    17 Mar 2021

  • REC opinion

    Further Information Favourable Opinion