None listed
Conditions
Brief summary
The Australian Mepolizumab Registry (AMR) collects data on individuals with severe refractory asthma who receive mepolizumab for the management of their asthma. This includes those with treatment-resistant severe eosinophilic asthma who receive Pharmaceutical Benefit Scheme (PBS)-subsidised mepolizumab, and those with treatment-resistant severe asthma who receive mepolizumab outside of the PBS scheme. The AMR provide a mechanism for researchers and clinicians to better understand the use, effectiveness, and safety associated with the treatment of severe asthma with mepolizumab.
Interventions
A 4 year observation of patients treated with Mepolizumab for severe asthma.
Prior to starting treatment with Mepolizumab, patients will complete questionnaires concerning their asthma control and health-related quality of life. Details of medical history, asthma exacerbations and medication use are also recorded. Lung function and blood biomarkers (blood eosinophils, serum IgE) are also reported. Follow up data collection is performed at approximately 4, 7, 12, 18, 24, 36, 48 months after start
A 4 year observation of patients treated with Mepolizumab for severe asthma. Prior to starting treatment with Mepolizumab, patients will complete questionnaires concerning their asthma control and health-related quality of life. Details of medical history, asthma exacerbations and medication use are also recorded. Lung function and blood biomarkers (blood eosinophils, serum IgE) are also reported. Follow up data collection is performed at approximately 4, 7, 12, 18, 24, 36, 48 months after starting treatment. Data collection is aligned with standard clinic visits and assessments. Patients will again complete questionnaires and clinical outcomes will also be reported.
Sponsors
Hunter New England Local Health District
Eligibility
Sex/Gender
All
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Able to provide informed written consent 2. Age greater than or equal to 12 years 3. Asthma diagnosis confirmed by doctor or hospital and documented for at least 1 year 4. Confirmed variable airflow obstruction (1 or more of the following) OR as required by current PBS criteria : a. FEV1 reversibility greater than or equal to 12% and greater than or equal to 200mL at baseline within 30 minutes after administration of salbutamol (200-400micrograms), OR b. Airway hyper-responsiveness (AHR) defined as >20% decline in FEV1 during a direct bronchial provocation test or >15% decline during an indirect test, OR c. Peak Expiratory Flow (PEF) variability of >15% between the 2 highest and 2 lowest peak expiratory flow rates during 14 days 5. Optimised asthma management skills (formal assessment of and adherence to correct inhaler technique, documented in medical records) 6. Eligible to commence mepolizumab via the Pharmaceutical Benefit Scheme (PBS)-subsidised criteria OR outside of the PBS restrictions 7. Optimised asthma therapy (unless contraindicated or not tolerated): a. greater than or equal to 12 months maximal inhaled therapy with adherence and correct technique documented, including: i. High dose inhaled corticosteroid (ICS) ii. Long-acting beta-2 agonist (LABA) therapy AND b. Treatment with oral corticosteroids (OCS) 8. Uncontrolled asthma, as defined by: a. Asthma Control Questionnaire (ACQ-5) score AND b. One of the following experienced in the previous year: i. greater than or equal to 1 admission to hospital for a severe asthma exacerbation, OR ii. greater than or equal to 1 severe asthma exacerbation requiring documented use of systemic corticosteroids (OCS initiated or increased for at least 3 days, or parenteral corticosteroids) prescribed/supervised by a physician. 9. Eosinophilic asthma as determined from peripheral blood eosinophil count (as according to the current PBS criteria).
Exclusion criteria
1. People highly dependent on medical care 2. Cognitive impairment preventing completion of data collection forms
Outcome results
None listed