CompletedNot Applicable

Severe Asthma, MepolizumaB and Affect: SAMBA Study

United Kingdom120 participantsStarted 2021-09-09

Plain-language summary

This is a real-life pragmatic non-randomised study to explore the impact of mepolizumab on the emotional and affective outcomes of patients with severe eosinophilic asthma and their partners. It will be conducted in two quantitative stages (Phases 1 and 2) with an additional third qualitative component (Phase 3).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Phase 1: * Age 18 or over * Having a diagnosis of severe eosinophilic asthma * Currently on mepolizumab (Nucala®) treatment * At least basic command of English * Giving written informed consent Phase 2 Patient eligibility Inclusion criteria * Age 18 or over * Having a diagnosis of severe eosinophilic asthma * Scheduled to start mepolizumab (Nucala®) treatment * At least basic command of English (for sub-study: conversational level of English that does not require a translator) * Giving written informed consent * Co-habiting with an intimate partner who is willing to participate in the study Exclusion criteria * Participated in Phase 1 * Currently on mepolizumab (Nucala®) treatment * Major psychiatric disorder currently under treatment * History of any major psychiatric disorder in the last 5 years, excluding depressive and anxiety disorders that can be included if treatment or change of treatment (including change in dose of medication) has not started within the last 6 months * Any diagnosed severe comorbid chronic condition that, in the opinion of the patient's asthma physician, might impact on the patient's or partner's affective state (e.g. cancer, diabetes, heart failure, chronic liver disease, chronic kidney disease, autoimmune or neuro-degenerative disease). * Partners only: diagnosis of severe eosinophilic asthma * Death of spouse, main informal carer or first-degree family member within the last 3 months * Current oral corticosteroid mainten…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This SAMBA study specifically looked at emotional wellbeing and psychological distress in people with severe eosinophilic asthma treated with mepolizumab — can you tell me what the results showed, and whether patients actually reported meaningful improvements in anxiety, depression, or emotional adjustment?
2Since this trial measured something called 'emotional composition' using the Geneva Emotions Wheel, does that kind of psychological outcome actually change how you would manage my asthma treatment, or is it more of a research tool that wouldn't affect my care directly?
3I have severe eosinophilic asthma and I do struggle with stress and anxiety around managing it — based on what this study found, is mepolizumab something you think I should be discussing as an option, and are the psychological benefits a real consideration alongside the physical ones?
4This study is now completed but listed as Phase NA, which sounds like it may have been more of an observational or real-world study rather than a controlled drug trial — does that affect how confident you are in the findings compared to a standard randomized trial?
5Given that this study looked at psychosocial stress and coping behavior alongside asthma treatment, are there mental health supports or referrals you'd recommend I consider as part of managing severe asthma, regardless of what medication path we choose?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Emotional Composition (Using the Geneva Emotions Wheel)

Timeframe: Change to one year after start of treatment

Trial details

NCT IDNCT04680611

SponsorUniversity Hospital Southampton NHS Foundation Trust

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-03-26

Results submitted2025-12-11

View on ClinicalTrials.gov More Severe Eosinophilic Asthma trials