A Prospective Observational Study on the Effect of Mepolizumab add-on Therapy on Daily Physical Activity in Patients With Severe Eosinophilic Asthma
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in daily movement intensity
研究概览
简要总结
Daily physical activity in adult patients with asthma remains overlooked. Limited evidence demonstrates reduced levels of daily physical activity in asthma populations but studies examining the potential effect of available therapies are missing. This study aims to investigate the overall levels of daily physical activity in patients with severe eosinophilic asthma and whether anti-interleukin-5 therapy with mepolizumab, on top of existing, maximal, and optimised asthma treatment, may improve patient's daily physical activity.
详细描述
A multi-centre, prospective, observational study of continuous patients who fulfil the definition of severe asthma and the criteria for mepolizumab (nucala; GSK) therapy. Patients have their daily physical activity recorded using triaxial accelerometry (DynaPort MoveMonitor; McRoberts) prior to treatment, and at 6 and 12 months of mepolizumab therapy (100 mg subcutaneously once every 4 weeks).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
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
- •Severe asthma
- •Criteria for mepolizumab therapy: blood eosinophils ≥150 cells/μL at screening or ≥300 cells/μL in the past 12 months.
排除标准
- •Comorbidities limiting physical activity
结局指标
主要结局
Change in daily movement intensity
时间窗: 7 days
Movement intensity in m/s\^2
Change in daily moving time
时间窗: 7 days
Moving time in minutes
Change in daily time in moderate-to-vigorous-intensity activity
时间窗: 7 days
Time in moderate-to-vigorous-intensity activity in minutes
Change in daily steps
时间窗: 7 days
Step count
次要结局
未报告次要终点
研究者
Marios Panagiotou
Respiratory Physician, PhD student
Sotiria General Hospital