Severe Asthma, MepolizumaB and Affect: SAMBA Study (NCT04680611) | Clinical Trial Compass
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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 range18 Years
SexALL
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…
What they're measuring
1
Change in emotional composition (using the Geneva Emotions Wheel)
Timeframe: Phase 1: on enrolment. Phase 2: change to one year after start of treatment
Trial details
NCT IDNCT04680611
SponsorUniversity Hospital Southampton NHS Foundation Trust