NCT04680611Completed
Severe Asthma, MepolizumaB and Affect: SAMBA Study
The Biopsychosocial Impact of Mepolizumab in Severe Eosinophilic Asthma on Quantitative and Qualitative Emotional and Affective Outcomes in Patients and Partners
Source: ClinicalTrials.gov · Last updated 13 Jul 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 120 (actual)
- First submitted
- 8 Dec 2020
- Start date
- 9 Sept 2021
- Primary completion date
- 26 Mar 2025
- Lead sponsor
- University Hospital Southampton NHS Foundation Trust
- Diseases
- Asthma
- NCT number
- NCT04680611
What you commit to
- Study type: Observational
- Participants enrolled: 120
- From 9 Sept 2021 to the primary completion date, 26 Mar 2025
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently on mepolizumab (Nucala®) treatment
- Current oral corticosteroid maintenance treatment
- Partner eligibility Inclusion criteria
- 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.
Other illness
- 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).
- 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).
Age
- Age 18 or over
Other
- Participated in Phase 1
- Partners only: diagnosis of severe eosinophilic asthma
- Death of spouse, main informal carer or first-degree family member within the last 3 months
- 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
- Participated in Phase 1
- Diagnosis of severe eosinophilic asthma
- Death of spouse, main informal carer or first-degree family member within the last 3 months
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Respiratory Medicine, Aberdeen Royal Infirmary Coordinator of this site? Confirm its status | Aberdeen | United Kingdom | Unknown status |
| Glasgow Gartnavel General Hospital Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Unknown status |
| Hull University Teaching Hospitals NHS Trust Coordinator of this site? Confirm its status | Hull | United Kingdom | Unknown status |
| Portsmouth Hospitals NHS Trust Coordinator of this site? Confirm its status | Portsmouth | United Kingdom | Unknown status |
| Judit Varkonyi-Sepp Coordinator of this site? Confirm its status | Southampton | United Kingdom | Unknown status |
| Pinderfields Hospital Coordinator of this site? Confirm its status | Wakefield | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.