Exploring the emotional impact of mepolizumab in severe asthma patients
The Biopsychosocial Impact of Mepolizumab in Severe Eosinophilic Asthma on Quantitative and Qualitative Emotional and Affective Outcomes in Patients and Partners
This study is trying to see how the asthma medication mepolizumab affects the emotional well-being of people with severe asthma and their partners.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital Southampton NHS Foundation Trust Academic / other |
| Drugs / interventions | mepolizumab |
| Locations | 6 sites (Aberdeen, Grampian and 5 other locations) |
| Trial ID | NCT04680611 on ClinicalTrials.gov |
What this trial studies
This observational study investigates how mepolizumab affects the emotional and psychological well-being of patients with severe eosinophilic asthma and their partners. It consists of three phases: the first phase collects emotional data from patients currently on mepolizumab, while the second phase follows new patients starting the treatment over 12 months. The study aims to correlate asthma control with emotional states and quality of life using various assessment tools. The findings will help understand the broader impacts of asthma treatment beyond physical symptoms.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and over with a diagnosis of severe eosinophilic asthma who are either currently on or scheduled to start mepolizumab treatment.
Not a fit: Patients with major psychiatric disorders currently under treatment or those who have participated in Phase 1 will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of the emotional benefits of mepolizumab treatment for patients with severe asthma.
How similar studies have performed: While this study explores a novel approach to understanding the emotional impacts of asthma treatment, similar studies have shown the importance of addressing psychological factors in chronic illness management.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Aberdeen, Grampian and 5 other locations
- Department of Respiratory Medicine, Aberdeen Royal Infirmary — Aberdeen, Grampian, United Kingdom (Recruiting)
- Judit Varkonyi-Sepp — Southampton, Hampshire, United Kingdom (Recruiting)
- Hull University Teaching Hospitals NHS Trust — Hull, Yorkshire, United Kingdom (Recruiting)
- Pinderfields Hospital — Wakefield, Yorkshire, United Kingdom (Recruiting)
- Glasgow Gartnavel General Hospital — Glasgow, United Kingdom (Recruiting)
- Portsmouth Hospitals NHS Trust — Portsmouth, United Kingdom (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.