Severe Asthma, MepolizumaB and Affect: SAMBA Study

NCT04680611 | Unknown

• 1 other identifier: RHM MED1740
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 6

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 be conducted in two quantitative stages (Phases 1 and 2) with an additional third qualitative component (Phase 3).

Conditions

Severe Eosinophilic Asthma; Psychological Distress; Anxiety; Depression; Psychological Stress; Psychological Adjustment; Psychological Disorder; Psychosocial Problem; Psychosocial Stressor; Psychological; Emotions; Emotional Disorder; Emotional Dysfunction; Emotional Distress; Adjustment; Adjustment, Emotional; Coping Behavior

Outcome Measures

Primary Outcomes (1)

• Change in emotional composition (using the Geneva Emotions Wheel)

  A 20-item self-report questionnaire identifying 20 discrete emotions with positive or negative valence. The intensity of each emotion can be marked on a 6-point Likert-type scale. Lower scores indicate lower intensity of emotions, higher scores indicate higher intensity of emotions. Respondents can add free text. Can be used a a variety of applications. The emotion labels used in the study have been modified with input from representatives of the target study population to ensure complete relevance to the study..

  Phase 1: on enrolment. Phase 2: change to one year after start of treatment

Secondary Outcomes (5)

• change in affective state (using the Hospital Anxiety and Depression Scale)

  Phase 1: on enrolment. Phase 2: change from baseline to 1 year after start of treatment

• change in self-reported asthma symptom control (using the Asthma Control Questionnaire)

  Phase 1: on enrolment. Phase 2: change from baseline to 1 year after start of treatment

• change in functioning and quality of life (using the St Georges Respiratory Questionnaire)

  Phase 1: on enrolment Phase 2: change from baseline to 1 year after start of treatment

• change in asthma-related quality of life (using the Severe Asthma Questionnaire)

  Phase 1: on enrolment Phase 2: change from baseline to 1 year after start of treatment

• change in illness perception (using the Brief Illness Perception Questionnaire)

  Phase 2: change from basline to 1 year after start of treatment

Other Outcomes (2)

• change in Inflammatory panel and chemokines

  Phase 2 only: change from baseline to 1 year after start of treatment

• lived experiences and psychological processes (using Semi-structured interviews)

  Phase 2 only: change from baseline to 1 year after start of treatment

Study Arms (5)

Patients with severe eosinophilic asthma Phase 1

Patients with severe eosinophilic asthma on Nucala(R) treatment

Other: no study intervention. Patients receive standard clinical care

Patients with severe eosinophilic asthma Phase 2

Patients with severe eosinophilic asthma to start Nucala(R) treatment

Other: no study intervention. Patients receive standard clinical care

Partners of patients with severe eosinophilic asthma Phase 2

Partners of patients with severe eosinophilic asthma to start Nucala(R) treatment

Phase 3: Patients with severe eosinophilic asthma from Phase 2

A sub-group of patients who participate in Phase 2

Other: no study intervention. Patients receive standard clinical care

Phase 3: Partners of patients in Phase 3

Partners of the sub-group of patients who participate in Phase 3

Interventions

no study intervention. Patients receive standard clinical care OTHER

no intervention. observational study

Also known as: no intervention. observational study

Patients with severe eosinophilic asthma Phase 1; Patients with severe eosinophilic asthma Phase 2; Phase 3: Patients with severe eosinophilic asthma from Phase 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with severe eosinophilic asthma on mepolizumab treatment (Phase 1) Patients with sereve eosinophilic asthma who are to start mepolizumab treatment and their partners ( Phase 2 and 3)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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
• 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.

Sponsors & Collaborators

• University Hospital Southampton NHS Foundation Trust: lead
• Portsmouth Hospitals NHS Trust: collaborator
• University of Derby: collaborator

Study Sites (6)

Department of Respiratory Medicine, Aberdeen Royal Infirmary

Aberdeen, Grampian, AB25 2ZN, United Kingdom

RECRUITING

Judit Varkonyi-Sepp

Southampton, Hampshire, SO166YD, United Kingdom

RECRUITING

Hull University Teaching Hospitals NHS Trust

Hull, Yorkshire, HU16 5JQ, United Kingdom

RECRUITING

Pinderfields Hospital

Wakefield, Yorkshire, WF1 4DG, United Kingdom

RECRUITING

Glasgow Gartnavel General Hospital

Glasgow, G12 0YN, United Kingdom

RECRUITING

Portsmouth Hospitals NHS Trust

Portsmouth, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

inflammatory panel, chemokines

MeSH Terms

Conditions

Pulmonary Eosinophilia; Anxiety Disorders; Depression; Stress, Psychological; Mental Disorders

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypereosinophilic Syndrome; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Behavioral Symptoms; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2020
• First Posted: December 23, 2020
• Study Start: September 9, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: October 6, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (6)