ACTRN12618001497291暂停未知
Australian Mepolizumab Registry for Severe Asthma
试验速览
- 阶段
- 未知
- 状态
- 暂停
- 入组人数
- 400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 12 Years 至 o limit（—）
- 性别
- All
入选标准
- •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):
- •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. FEV1 less than or equal to 80% predicted
- •7. Eligible to commence mepolizumab via the Pharmaceutical Benefit Scheme (PBS)-subsidised criteria OR outside of the PBS restrictions
- •8. 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
- •b. Treatment with oral corticosteroids (OCS)
- •9. 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.
- •10. Eosinophilic asthma as determined from peripheral blood eosinophil count (as according to the current PBS criteria).
排除标准
- •1. People highly dependent on medical care
- •2. Cognitive impairment preventing completion of data collection forms
研究者
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