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Status:

UNKNOWN

Severe Asthma, MepolizumaB and Affect: SAMBA Study

Lead Sponsor:

University Hospital Southampton NHS Foundation Trust

Collaborating Sponsors:

Portsmouth Hospitals NHS Trust

University of Derby

Conditions:

Severe Eosinophilic Asthma

Psychological Distress

Eligibility:

All Genders

18+ years

Brief Summary

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 ...

Detailed Description

This longitudinal observational study will investigate the relationship between patients' asthma control and emotional states and quality of life in patients and their partners where patients have sev...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

    Key Trial Info

    Start Date :

    September 9 2021

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ESTIMATED

    End Date :

    December 31 2024

    Estimated Enrollment :

    120 Patients enrolled

    Trial Details

    Trial ID

    NCT04680611

    Start Date

    September 9 2021

    End Date

    December 31 2024

    Last Update

    October 6 2023

    Active Locations (6)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 2 (6 locations)

    1

    Department of Respiratory Medicine, Aberdeen Royal Infirmary

    Aberdeen, Grampian, United Kingdom, AB25 2ZN

    2

    Judit Varkonyi-Sepp

    Southampton, Hampshire, United Kingdom, SO166YD

    3

    Hull University Teaching Hospitals NHS Trust

    Hull, Yorkshire, United Kingdom, HU16 5JQ

    4

    Pinderfields Hospital

    Wakefield, Yorkshire, United Kingdom, WF1 4DG