None listed
Conditions
Brief summary
The Australian Benralizumab Registry (the ABR) wil collect and report on data from people with severe refractory eosinophilic asthma who receive benralizumab: o as part of the PBS subsidised benralizumab treatment cycle, and the Pharmaceutical Benefits Scheme (PBS) Section 100 Special Authority Program, or o who receive benralizumab for severe refractory eosinophilic asthma outside of the PBS restrictions. The ABR will provide a mechanism for sharing information which will help researchers and clinicians to better understand the use, efficacy, and safety associated with the treatment of severe asthma with benralizumab. All information collected from participating sites will be securely stored in the main data repository. Access to the ABR will be restricted to authorised users. The ABR will report regularly on characteristics and outcomes for this population.
Interventions
Severe asthma is defined as ‘Uncontrolled asthma which can result in risk of frequent severe exacerbation (or death) and/or adverse reactions to medications and/or chronic morbidity (including impaired lung function or reduced lung growth in children).’
The Australian Benralizumab Registry will:
· collect and report on data from people with severe refractory eosinophilic asthma who receive benralizumab:
a) as part of the PBS subsidised benralizumab treatment cycle, and the Pharmaceutical Bene
Severe asthma is defined as ‘Uncontrolled asthma which can result in risk of frequent severe exacerbation (or death) and/or adverse reactions to medications and/or chronic morbidity (including impaired lung function or reduced lung growth in children).’ The Australian Benralizumab Registry will: · collect and report on data from people with severe refractory eosinophilic asthma who receive benralizumab: a) as part of the PBS subsidised benralizumab treatment cycle, and the Pharmaceutical Benefits Scheme (PBS) Section 100 Special Authority Program, or b) who receive benralizumab for severe refractory eosinophilic asthma outside of the PBS restrictions. Patients will be followed prospectively for 2 years and data collection will be conducted every 6 months. At patients' visits, data on demographics, anthropometrics, Quality of Life and clinical data will be collected.
Sponsors
The Thoracic Society of Australia and New Zealand
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. adults aged 18 years and over; 2. provision of informed consent prior to any study specific procedures; 3. confirmed asthma diagnosis; 4. using maximum therapy [inhaled high dose of corticosteroid and 2nd controller]; 5. uncontrolled asthma [currently, or on reduction in maximal therapy], which constitutes each of: a. poor symptom control: ACQ-5>=2; b. >=1 severe exacerbation in the past 12 months; c. airflow obstruction: FEV1<80% predicted; 6. optimised asthma management skills; 7. triggers and relevant co-morbidity have been assessed and managed; 8. eosinophilic asthma as determined from airway sample (induced sputum, BAL >3%) or peripheral blood sample; 9. Blood eosinophil count >=300/µL in the previous 12 months;
Exclusion criteria
1. unable to complete study data collection requirements, unable to participate over 2 year period; 2. people highly dependent on medical care; 3. cognitive impairment preventing completion of data collection forms.
Outcome results
None listed