The Biopsychosocial Impact of Mepolizumab in Severe Eosinophilic Asthma on Quantitative and Qualitative Emotional and Affective Outcomes in Patients and Partners

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Other
Study Type: Observational
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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

Locations
Other Locations
United Kingdom
Department of Respiratory Medicine, Aberdeen Royal Infirmary
RECRUITING
Aberdeen
Glasgow Gartnavel General Hospital
RECRUITING
Glasgow
Hull University Teaching Hospitals NHS Trust
RECRUITING
Hull
Portsmouth Hospitals NHS Trust
RECRUITING
Portsmouth
Judit Varkonyi-Sepp
RECRUITING
Southampton
Pinderfields Hospital
RECRUITING
Wakefield
Time Frame
Start Date: 2021-09-09
Estimated Completion Date: 2024-12-31
Participants
Target number of participants: 120
Treatments
Patients with severe eosinophilic asthma Phase 1
Patients with severe eosinophilic asthma on Nucala(R) treatment
Patients with severe eosinophilic asthma Phase 2
Patients with severe eosinophilic asthma to start Nucala(R) treatment
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
Phase 3: Partners of patients in Phase 3
Partners of the sub-group of patients who participate in Phase 3
Sponsors
Leads: University Hospital Southampton NHS Foundation Trust
Collaborators: University of Derby, Portsmouth Hospitals NHS Trust

This content was sourced from clinicaltrials.gov