Using the Aflo™ Digital Smart Spacer Platform to Improve Inhaler Technique in Children With Uncontrolled Asthma: A Prospective Pilot Study - INSPIRE-KIDS (INhaler SPacer Improvement & Real-time Education - KIDS)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Change in inhaler technique errors
研究概览
简要总结
This pilot study evaluates the feasibility, usability, and potential effect of the aflo™ Smart Spacer platform in children aged 6-18 with uncontrolled asthma using pMDIs and spacers. The study investigates changes in inhaler technique, asthma control, and lung function following 3 months of daily use of the CE-marked aflo™ device.
详细描述
Asthma management in children is often limited by inadequate inhaler technique and adherence. The aflo™ Smart Spacer is a CE-marked device that measures both adherence and inhaler technique, providing real-time feedback, medication reminders, and symptom tracking.
This single-arm, single-center, 12-week pilot study aims to assess the platform's potential effect on inhaler technique errors, its feasibility in pediatric clinical practice, and usability. Participants will use the device for 3 months in daily life, with assessments at baseline and week 12, and phone calls at weeks 4 and 8. Findings will inform the design and sample size of a future controlled clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 6-18 years
- •Physician-diagnosed asthma
- •Using ICS ± LABA ± LAMA ± SABA via pMDI and spacer suitable for aflo™
- •Uncontrolled asthma (ACT <19 and/or recent exacerbation and/or suspected nonadherence/poor technique)
- •Access to an Apple or Android smartphone (OS ≥ 4.3)
- •Willing and able to give assent/consent (parents/guardians for minors)
排除标准
- •Chronic lung disease other than asthma
- •Significant cardiac disease
- •Not able to understand Dutch sufficiently
- •No access to stable mobile internet
研究组 & 干预措施
Aflo™ Smart Spacer Platform
Participants receive the aflo™ device for home use during 3 months.
干预措施: Aflo™ Smart Spacer (Device)
结局指标
主要结局
Change in inhaler technique errors
时间窗: Baseline (mean of first 3 days) vs. end-of-study (mean of last 3 days)
Errors detected by aflo™ sensor relating to pMDI-spacer technique steps.
次要结局
- Asthma Control Test (ACT)(Baseline vs. week 12)
- Change in FEV1/FVC ratio(Baseline vs. week 12)
- Change in FEF25-75(Baseline vs. week 12)
- Change in FEF75(Baseline vs. week 12)
- Fractional exhaled nitric oxide (FeNO)(Baseline vs. week 12)
- Proportion of prescribed inhalations taken(3 months (from baseline to final study visit))
- Asthma exacerbations(3 months (from baseline to final study visit))
- Short-acting β-agonist (SABA) use(3 months (from baseline to final study visit))
- System Usability Scale (SUS)(SUS score measured once at week 12 (final study visit))