Real-world Experience of Dupilumab for the Treatment of Severe Asthma in the United Kingdom: a Retrospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Oral corticosteroid (OCS) dose
研究概览
简要总结
The purpose of this retrospective medical record review is to describe the real-world clinical effectiveness of dupilumab with patients in the United Kingdom with severe asthma.
详细描述
Participants initiating treatment with dupilumab in the UK between 5th July 2019 and 12th August 2021 will be included in the study record review, permitting participation in research and if medical records are available for review. No intervention will be administered in this clinical trial. Data will be collected from hospital medical records and other hospital databases.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult participants (aged ≥18 years at index) with severe asthma, initiated with dupilumab treatment (≥1 dose) between 07/05/2019 (EU licence) and 08/12/2021 • Participants with ≥1 routine asthma clinic visit recorded within 6 months prior to or on the date of dupilumab initiation and ≥1 routine asthma clinic visit recorded between 9 and 16 months post-dupilumab initiation
排除标准
- •Participants known to have opted out of participation in research • Participants whose medical records are not available for review The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
结局指标
主要结局
Oral corticosteroid (OCS) dose
时间窗: Up to 25 months
Measured per day
Annual asthma exacerbation rate
时间窗: Up to 25 months
The annual exacerbation rate will be calculated as the sum of OCS exacerbations and the hospital asthma exacerbations that occurred more than 7 days separated from other exacerbations. Exacerbations will be defined according to whether or not the patient was receiving asthma maintenance OCS.
Forced expiratory volume in one second (FEV1)
时间窗: Up to 25 months
FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer measured in L
Peak expiratory flow rate (PEF)
时间窗: Up to 25 months
The PEF is a participant's maximum speed of expiration, as measured with a peak flow meter measured in L/min.
Asthma Quality of Life Questionnaire (AQLQ) score
时间窗: Up to 25 months
Overall scores for the mini-AQLQ and the AQLQ have been reported to be very similar but results will be reported separately according to the version used. Differences in AQLQ will only be calculated where the same version was used for the time points being compared. The overall score is 1 to 7. Higher AQLQ scores indicate better health-related quality of life.
Asthma Control Questionnaire (ACQ) score
时间窗: Up to 25 months
Total scores for the different versions of ACQ (5/6/7) are highly correlated and measurement properties are reported to be similar but results will be reported separately according to the version used. Differences in ACQ will only be calculated where the same version was used for the time points being compared. The score ranges from 0 (totally controlled) and 6 (severely uncontrolled). A high score indicates low asthma control.
次要结局
- Inhaled corticosteroid dose(At baseline)
- Body mass index (BMI [kg/m2])(At baseline)
- Dupilumab treatment duration(Up to 25 months)