Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
120 participants
OBSERVATIONAL
2021-09-09
2024-12-31
Brief Summary
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Detailed Description
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Phase 1 In order to extend our pilot study findings and help inform the second stage, investigators will gather Geneva Emotional Wheel (GEW) data from 30 patients currently treated and benefitting from mepolizumab (Nucala®). This data will be compared to the GEW data investigators have already gathered from patients with severe asthma not receiving treatment with mepolizumab (Nucala®). This will provide timely data to support a publication on the GEW findings in severe asthma and allow the description of the impact of mepolizumab (Nucala®). In addition, it will help provide power calculations for a prospective study. Parallel assessment of quality of life (SGRQ and SAQ) and anxiety and depression (HADS) will be made to evaluate the relationship between GEW, SGRQ, SAQ and HADS scores.
Phase 2 In the second stage, investigators will conduct a prospective study of 45 patients newly prescribed mepolizumab (Nucala®) and their partners measuring participants' emotional composition before and 6 and 12 months after starting treatment. The choice of 60 has been based on likely power requirements but was adjusted to 45 based in Phase 1 results. Investigators will also compare the outcomes from the GEW with other standard outcome measures (HADS, ACQ, SGRQ, SAQ, BIPQ), to establish relationship between changes in these measures and changes in GEW scores, to evaluate the utility of the GEW. This will help determine if the GEW reflects changes in asthma control or whether it is reflecting improvements that the current established instruments do not recognise and allow us to quantify the magnitude of that effect. As these patients will receive mepolizumab as part of their clinical care for a year, whilst assessment of clinical efficacy is being established, investigators will gather data on oral steroid dependent exacerbations (severe exacerbations) during this year and relate to their historic exacerbation history in the year before. Evaluation will be made as to whether the 6-month improvement in GEW scores predicts impact of mepolizumab on exacerbation reduction over the first year of administration. In addition, improvements in the GEW will be explored in relationship to systemic inflammatory impact, with measures of blood eosinophils and serum inflammatory biomarkers (Olink inflammatory panel) at baseline, 6 months and 1 year.
Phase 3 Finally, in addition, investigators will conduct qualitative research in the form of semi-structured interviews with a sub-set of couples (20 couples or less if no new information emerges from the interviews) to gain a more detailed insight and identify common key aspects in their subjective experiences, quality of life and emotional processes before starting treatment and after being on treatment with mepolizumab for 6 months.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients with severe eosinophilic asthma Phase 1
Patients with severe eosinophilic asthma on Nucala(R) treatment
no study intervention. Patients receive standard clinical care
no intervention. observational study
Patients with severe eosinophilic asthma Phase 2
Patients with severe eosinophilic asthma to start Nucala(R) treatment
no study intervention. Patients receive standard clinical care
no intervention. observational study
Partners of patients with severe eosinophilic asthma Phase 2
Partners of patients with severe eosinophilic asthma to start Nucala(R) treatment
No interventions assigned to this group
Phase 3: Patients with severe eosinophilic asthma from Phase 2
A sub-group of patients who participate in Phase 2
no study intervention. Patients receive standard clinical care
no intervention. observational study
Phase 3: Partners of patients in Phase 3
Partners of the sub-group of patients who participate in Phase 3
No interventions assigned to this group
Interventions
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no study intervention. Patients receive standard clinical care
no intervention. observational study
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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 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
* 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
* 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:
18 Years
ALL
No
Sponsors
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Portsmouth Hospitals NHS Trust
OTHER_GOV
University of Derby
OTHER
University Hospital Southampton NHS Foundation Trust
OTHER
Responsible Party
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Locations
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Department of Respiratory Medicine, Aberdeen Royal Infirmary
Aberdeen, Grampian, United Kingdom
Judit Varkonyi-Sepp
Southampton, Hampshire, United Kingdom
Hull University Teaching Hospitals NHS Trust
Hull, Yorkshire, United Kingdom
Pinderfields Hospital
Wakefield, Yorkshire, United Kingdom
Glasgow Gartnavel General Hospital
Glasgow, , United Kingdom
Portsmouth Hospitals NHS Trust
Portsmouth, , United Kingdom
Countries
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Facility Contacts
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Other Identifiers
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RHM MED1740
Identifier Type: -
Identifier Source: org_study_id
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