Open Label, Observational Study for Children & Adolescent With Severe Asthma With an Eosinophilic Phenotype Treated With Mepolizumab
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- To compare the rates of clinically significant asthma exacerbations in the pre-exposure and the 12-month post-exposure period with mepolizumab treatment.
研究概览
简要总结
Open label, observational cohort study conducted to collect demographics, clinical characteristics and outcome observational data from children (6-17 years) with a clinical diagnosis of severe asthma in 2 countries (Spain and United Kingdom), in public institutions.
All eligible participants who have a physician decision to initiate mepolizumab treatment and are consented for the study will be observed.
Subjects must have received mepolizumab (Nucala) since authorisation by EMEA in September 2018 (in Spain since December 2019) as an add-on treatment for severe refractory eosinophilic asthma in paediatric patients aged six up to 17 years. The study will be implemented in 16 investigating sites (10 in Spain and 6 in UK). The assignment of a patient to a particular therapeutic strategy is not decided in advance by the study protocol, but is determined by the usual practice of medicine, and the decision to prescribe a particular drug is clearly dissociated from the decision to include the patient in the study.
Eligible participants will meet the local reimbursement criteria. The study will be managed by IQVIA. No patient-identifying information will be transferred to the sponsor nor the CRO.
No visits should be scheduled specifically for this observational study, data will be collected at usual asthma healthcare visits (routine or unscheduled, remote or face to face). If a participant is seen by their physician for monthly mepolizumab injections, data for healthcare utilization, asthma medications and any recent lung function assessment will be collected on a monthly basis. When the participant is seen less frequently by their physician (for example when mepolizumab injection is given at a different site or at home) this data will be collected at usual asthma healthcare visits, which are likely to occur less frequently.
The index date will be defined as the date of the first mepolizumab injection administration during the study (i.e. treatment initiation). To accommodate local healthcare practice, this will be according to local healthcare practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient who provides his/her written informed Consent to participate prior to commencing any study related activities.
- •Children & Adolescent aged 6-17 years at mepolizumab initiation
- •Patient with a current clinical diagnosis of severe asthma (as per GINA / ATS / ERS / BTS criteria) and eosinophilic phenotype (as per mepolizumab licence) at mepolizumab initiation
- •Patient currently under treatment or who initiates treatment with mepolizumab at the inclusion visit based on national asthma guidelines.
- •Patient with relevant paper or electronic-based medical records available for 12-months prior to enrolment date/ index date (date of first mepolizumab injection) for clinically significant asthma exacerbation.
排除标准
- •A participant will not be eligible for inclusion in this study if any of the following criteria apply:
- •Patient who does not meet the inclusion criteria.
- •Patient who has participated in an asthma monoclonal antibodies drug interventional clinical trial in the previous 12-months to mepolizumab initiation.
研究组 & 干预措施
Treated with Mepolizumab
干预措施: Mepolizumab (Drug)
结局指标
主要结局
To compare the rates of clinically significant asthma exacerbations in the pre-exposure and the 12-month post-exposure period with mepolizumab treatment.
时间窗: 12 months
次要结局
未报告次要终点