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Severe Asthma, MepolizumaB and Affect: SAMBA Study

CompletedN/A

Sponsor: University Hospital Southampton NHS Foundation Trust

Conditions: Severe Eosinophilic Asthma, Psychological Distress, Anxiety, Depression, Psychological Stress

Interventions: no study intervention. Patients receive standard clinical care

Countries: United Kingdom

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).

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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 maintenance treatment

Partner eligibility Inclusion criteria

* Age 18 or over
* At least basic command of English (for sub-study: conversational level of English that does not require a translator)
* Giving written informed consent
* Partners: Co-habiting with an intimate partner who has severe eosinophilic asthma and is willing to participate in the study

Exclusion criteria

* Participated in Phase 1
* Major psychiatric disorder currently under treatment
* Participant self-reported 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.
* Participant self-reported 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).
* Diagnosis of severe eosinophilic asthma
* Death of spouse, main informal carer or first-degree family member within the last 3 months
* Current oral corticosteroid maintenance treatment

Phase 3:

Phase 3 is a qualitative study on a sample of couples from Phase 2 therefore the same exclusion criteria will apply as in Phase 2.

Locations (6)

Aberdeen, Grampian, United Kingdom
Southampton, Hampshire, United Kingdom
Hull, Yorkshire, United Kingdom
Wakefield, Yorkshire, United Kingdom
Glasgow, United Kingdom
Portsmouth, United Kingdom