None listed
Conditions
Brief summary
People with severe asthma experience high symptom burden and frequent severe asthma attacks (termed exacerbations). In the last decade new biologic (antibody) treatments, including mepolizumab, have become available for severe asthma. Clinicians now recognise that mepolizumab treatment results in almost complete suppression of symptoms and exacerbations, termed remission, in around a quarter of patients. Remission of severe asthma is a relatively new concept, and further understanding of numerous aspects of remission is now required to promote remission as a clinical target and to further raise remission rates on treatment. To address this, in this study we aim to understand the clinical, immunological, economic and health literacy characteristics of long-term remission of severe asthma treated with mepolizumab.
Interventions
This study includes several embedded research projects:
1. Analysis of an existing registry-based dataset (no active participation, involves analysis of data already collected as part of ACTRN12618001497291).
2. A cross-sectional observational study conducted in four groups of participants:
a. Severe eosinophilic asthma not treated with a monoclonal antibody therapy
b. Severe eosinophilic asthma treated with mepolizumab in remission
c. Severe eosinophilic asthma treated with m
This study includes several embedded research projects: 1. Analysis of an existing registry-based dataset (no active participation, involves analysis of data already collected as part of ACTRN12618001497291). 2. A cross-sectional observational study conducted in four groups of participants: a. Severe eosinophilic asthma not treated with a monoclonal antibody therapy b. Severe eosinophilic asthma treated with mepolizumab in remission c. Severe eosinophilic asthma treated with mepolizumab not in remission d. Participants with no demonstrable obstructive airways disease. 3. A health economic evaluation of treatment-induced remission of severe asthma 4. A qualitative study of severe asthma patients treated with mepolizumab seeking their perspectives on asthma remission. Participants in groups a-d will attend a single cross-sectional biospecimen collection study visit. Each study visit will involve collection of blood, induced sputum and nasal biopsy samples, spirometry (lung function) tests, measurement of height and weight. The participant will also complete some questionnaires to gain information about general health or quality of life, medical history and medications and asthma symptoms. Study visits are anticipated to be 2-3 hours in duration. The study visit will be conducted by trained Research Staff. For participants in the qualitative study, this will involve a one-on-one conversation with a research staff member in the form of an interview. The interview will take up to 2 hours and will be audio-recorded. Interviews will either take place face-to-face at Hunter Medical Research Institute, by phone or online. Qualitative research interviews will occur on a separate occasion to the biospecimen collection visit, if participants have consented to participate in both. All participants will consent to: A. Completing questionnaires to obtain research data B. Allowing research personnel to access their medical record (NSW Hunter New England local health district electonic medical records). Participants will consent to either: C. Completing the tests involved in the study; and/or D. Attending a one-on-one research interview conducted by study personnel. Participants may optionally consent to: E. Storage of biospecimens for use in future research studies relating to asthma and respiratory disease.
Sponsors
University of Newcastle
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Primary outcome: Participants enrolled in Australian Mepolizumab Registry (ACTRN12618001497291) who have completed 2 years of treatment. Cross-sectional biospecimen and qualitative studies: 1. Group a: participants meeting Australian PBS criteria for commencement of mepolizumab therapy for severe eosinophilic asthma. 2. Group b: participants with severe asthma who have received mepolizumab treatment for 2 years who meet remission criteria. 3. Group c: participants with severe asthma who have received mepolizumab treatment for 2 years who do not meet remission criteria. 4. Group d: participants without current diagnosis of lung disease.
Exclusion criteria
Group a: Participant must not have received another PBS-subsidised biological medicine prescribed for severe asthma in the prior 3 months. All groups: No respiratory infection in prior 4 weeks to visit, and for participants with asthma (groups a-c) no exacerbation of asthma in prior 4 weeks to visit.
Outcome results
None listed