The Influence of Inhaled CorticoSteroids Adherence on Treatment Response to Mepolizumab in Severe Eosinophilic Asthma (CSAREA Study)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 250
- 主要终点
- To assess the influence of inhaled corticosteroids (ICS) adherence on treatment response to mepolizumab in severe eosinophilic asthma
研究概览
简要总结
The study aim is to look at the effect of the regular use of inhaled corticosteroids on the response and received from mepolizumab treatment which you are receiving or had received before.
详细描述
Examine the outcomes of 250 patients who have been treated with mepolizumab within BRSAS and compare the adherence to ICS in the responders and non-responder groups. If confirmed that non-adherence to ICS was related to poor response to mepolizumab, steps then will be undertaken to better monitor and enhance adherence to ICS to improve patients outcomes and response to mepolizumab treatment.
This study will rely on retrospective analysis of medically existing data within the service ,the adherence to ICS treatment will be measured using the prescription possession ratio "PPR" Data is available in the patients' GP records and forms part of the routine clinical practice of the severe asthma clinic to monitor adherence to ICS treatment.
For a significant number of patients ,such data will be already available within patient medical records held at University Hospitals Birmingham NHS Foundation Trust (UHB), however missing data is expected and in such cases GP surgeries will be contacted to obtain the PPR. Patients will be asked to agree to access to GP records as part of the informed consent process.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of 18 years of age or higher
- •Patients commenced on mepolizumab within the BRSAS network
- •Patients who have at least 1 mepolizumab injection and with at least 3 months follow-up data from the time of treatment initiation
- •Patients must be able and willing to give informed consent to participate in the study . An Interpreter will be provided for those patients where English is not their first language.
排除标准
- •Refusal or inability to provide informed consent
结局指标
主要结局
To assess the influence of inhaled corticosteroids (ICS) adherence on treatment response to mepolizumab in severe eosinophilic asthma
时间窗: 20 months
We will measure the adherence to inhaled corticosteroids treatment (ICS) during the period when patients were treated with the biologic treatment mepolizumab. Adherence to ICS will be measured in the form of prescription possession ratio (PPR) in which the number of prescription picked up by patients is divided by the expected number to be used in a specified period of time (one year). Adherence will be defined as a PPR of =\>70%. Mepolizumab responser group will be defined as those achieving reduction in the use of maintenance oral corticosteroids (OCS) and/or frequency of severe asthma exacerbations require OCS treatment by =\>50%. The adherence rates to ICS as measured by PPR in the mepolizumab responder and non-responder groups will be compared to find out if ICS non-adherence reduce response to meplizumab treatment in patients with severe eosinophilic asthma
次要结局
- To determine the response rate to mepolizumab in FeNO high and FeNO low groups (using variable cut off levels).(20 months)
- To describe the overall response and clinical outcomes to mepolizumab therapy in the BRSAS population.(20 months)
- to measure the frequency of severe exacerbations requiring oral corticosteroids treatment in patients treated with mepolizumab in patients with high/low fraction exhaled nitric oxide groups.(20 months)
- to describe baseline demographic and clinical characteristics of severe eosinophilic asthma patients treated with mepolizumab in the BRSAS network(20 months)
- To explore patient characteristics and predictors of poor ICS adherence(20 months)
- To determine the mepolizumab response rate in the ICS adherent versus non-adherent patients (at 70% ICS PPR cut off level).(20 months)
- To investigate the relationship between FeNO and ICS dose in patients on mepolizumab treatment.(20 months)
- To compare mean inhaled corticosteroids (ICS) daily dose and prescription possession ratio (PPR) in the period before and on mepolizumab treatment.(20 months)
- To investigate the relationship between the prescription possession ratio (PPR) of inhaled corticosteroids (ICS) and FeNO level in patients on mepolizumab treatment.(20 months)