Improving Asthma Treatment Using Inhaler Technology
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Impact on adherence to preventative medication use based on the mean percentage of prescribed doses taken daily over the study period
研究概览
简要总结
This study will use inhaler technology to observe and feedback overall patterns of medication use. We will look at whether this improves preventer inhaler use and reduces reliever inhaler overuse.
We will also assess whether inhaler technology is patient-friendly and cost effective, whether it helps with treatment decisions in asthma and whether it can help us to predict and prevent asthma attacks.
详细描述
The SmartTouch™ range of electronic casings will record the use of metered dose inhalers (MDI) by participants in the study. The actuation data can be remotely viewed and analyzed by the investigators.
The hypothesis is that employing such technology to measure medication patterns and to help provide patient feedback improves inhaler adherence and potentially clinical outcomes (asthma control and exacerbations) in asthma patients with recent asthma attacks in a practical, real-world setting.
We will assess whether electronic inhaler data capture can identify patients requiring more frequent reviews or treatment change and enable proactive self- management.
Using qualitative methods, we will explore participants' attitudes to their asthma management, whether the use of inhaler technology has had an impact on this and whether they found its use acceptable.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Use of systemic corticosteroids for worsening asthma (or an increase from baseline dose in patients on long-term oral corticosteroids) in the prior 12 months [i.e. at least one asthma exacerbation requiring additional systemic corticosteroid in the prior 12 months] patient reported.
- •Doctor's diagnosis of asthma for at least 12 months
- •On BTS step 2-5 treatment via MDI [monitoring devices to be utilised in the study are compatible with MDI inhalers]
- •Use of own internet-enabled and compatible mobile phone
排除标准
- •Diagnosis of COPD or onset of symptoms after the age of 40 in patients with ≥10 Pack Year History of smoking
- •Other clinically significant coexisting respiratory disease e.g. fibrosis, bronchiectasis
- •Patients on maintenance and reliever therapy ('SMART' or 'Fostair® MART')
结局指标
主要结局
Impact on adherence to preventative medication use based on the mean percentage of prescribed doses taken daily over the study period
时间窗: Upto 24 weeks (study duration)
Co-primary endpoint
Impact on adherence to reliever medication use based on the number of days with >16 actuations/day of Salbutamol taken in a 24-hour period
时间窗: Upto 24 weeks (study duration)
Co-primary endpoint
次要结局
- Patient acceptability via qualitative feedback with questionnaires(Upto 24 weeks (study duration))