Using a Digital Spacer for Inhaler Technique Education in Pediatric Asthma (INSPIRE-KIDS)
2026年8月31日 更新者：University Medical Center Groningen
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)
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (估计的)
12
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Job F.M. van Boven, Dr
- 电话号码：003150 361 7893
- 邮箱：j.f.m.van.boven@umcg.nl
研究联系人备份
- 姓名：Sophie I.M. Veenstra, Msc
- 电话号码：0031646938143
- 邮箱：s.i.m.veenstra@umcg.nl
学习地点
-
-
Provincie Groningen
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Groningen、Provincie Groningen、荷兰、9713 GZ
- UMC Groningen
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接触：
- Job F.M. van Boven, Dr
- 电话号码：003150 361 7893
- 邮箱：j.f.m.van.boven@umcg.nl
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接触：
- Sophie I.M. Veenstra, Msc
- 电话号码：0031646938143
- 邮箱：s.i.m.veenstra@umcg.nl
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
接受健康志愿者
不
描述
Inclusion Criteria:
- 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)
Exclusion Criteria:
- Chronic lung disease other than asthma
- Significant cardiac disease
- Not able to understand Dutch sufficiently
- No access to stable mobile internet
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Aflo™ Smart Spacer Platform
Participants receive the aflo™ device for home use during 3 months.
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A CE-marked digital spacer device that measures inhaler technique (step-by-step), adherence, daily symptoms, and provides real-time feedback and reminders via a linked mobile application.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in inhaler technique errors
大体时间：Baseline (mean of first 3 days) vs. end-of-study (mean of last 3 days)
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Errors detected by aflo™ sensor relating to pMDI-spacer technique steps.
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Baseline (mean of first 3 days) vs. end-of-study (mean of last 3 days)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Asthma Control Test (ACT)
大体时间：Baseline vs. week 12
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childrens ACT score change over time
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Baseline vs. week 12
|
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Change in FEV1/FVC ratio
大体时间：Baseline vs. week 12
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Change in FEV1/FVC ratio (%) from baseline to 3 months.
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Baseline vs. week 12
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Change in FEF25-75
大体时间：Baseline vs. week 12
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Change in FEF25-75 (L/s) from baseline to 3 months.
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Baseline vs. week 12
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Change in FEF75
大体时间：Baseline vs. week 12
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Change in FEF75 (L/s) from baseline to 3 months.
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Baseline vs. week 12
|
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Fractional exhaled nitric oxide (FeNO)
大体时间：Baseline vs. week 12
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Change in FeNO
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Baseline vs. week 12
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Proportion of prescribed inhalations taken
大体时间：3 months (from baseline to final study visit)
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Adherence to inhaled medication measured as the percentage of prescribed inhalations taken over the 3-month study period.
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3 months (from baseline to final study visit)
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Asthma exacerbations
大体时间：3 months (from baseline to final study visit)
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Number of asthma exacerbations during 3 months
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3 months (from baseline to final study visit)
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Short-acting β-agonist (SABA) use
大体时间：3 months (from baseline to final study visit)
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Number of SABA puffs measured by device data
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3 months (from baseline to final study visit)
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System Usability Scale (SUS)
大体时间：SUS score measured once at week 12 (final study visit)
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SUS score about the Aflo™ device
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SUS score measured once at week 12 (final study visit)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Job FM van Boven, Dr、Department of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, Groningen, The Netherlands
- 首席研究员：Annelies M Zwitserloot, Dr、Department of Pediatric Pulmonology and Allergy, Beatrix Children's Hospital, University Medical Center Groningen,, Groningen, The Netherlands
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年9月1日
初级完成 (估计的)
2027年1月1日
研究完成 (估计的)
2027年6月1日
研究注册日期
首次提交
2026年8月25日
首先提交符合 QC 标准的
2026年8月31日
首次发布 (实际的)
2026年9月3日
研究记录更新
最后更新发布 (实际的)
2026年9月3日
上次提交的符合 QC 标准的更新
2026年8月31日
最后验证
2025年11月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- PanamaID_23081
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
No individual participant data will be shared.
Only aggregate results may be shared upon publication.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.