Severe Asthma, MepolizumaB and Affect: SAMBA Study

Launched by UNIVERSITY HOSPITAL SOUTHAMPTON NHS FOUNDATION TRUST · Dec 22, 2020

Keywords

ClinConnect Summary

The SAMBA Study is investigating how a medication called mepolizumab (also known as Nucala®) affects not only the physical symptoms of severe eosinophilic asthma but also the emotional well-being of patients and their partners. The study aims to understand if this treatment can help reduce feelings of stress, anxiety, and depression in individuals with this type of asthma and their loved ones. It will be conducted in stages, including surveys and interviews to gather detailed information about their experiences.

To participate in the study, individuals must be at least 18 years old and have a diagnosis of severe eosinophilic asthma. Some participants will be currently receiving mepolizumab, while others will be starting the treatment. Partners of these patients are also eligible to join the study. Participants will need to provide written consent and have a basic understanding of English. Throughout the study, participants can expect to share their experiences and feelings regarding their asthma and emotional health, contributing to valuable insights that may help others in the future.

Gender

ALL

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.