Further Understanding asThma REmission: the FUTURE research program
- Conditions
- Severe AsthmaRespiratory - Asthma
- Registration Number
- ACTRN12623001271695
- Lead Sponsor
- niversity of Newcastle
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 80
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.
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.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Remission[The composite outcome of remission will be determined by review of data stored in the Australian Mepolizumab Registry, with remission defined as zero exacerbations and zero oral corticosteroid use during the previous 12 months and Asthma Control Questionnaire-5 score less than or equal to 1 at time of assessment. Assessed at 24 months or more of mepolizumab treatment.]
- Secondary Outcome Measures
Name Time Method