RecruitingNot ApplicableNCT06825871

Automated Inhaler Monitoring for Asthma Medication Usage


Sponsor

Boston Children's Hospital

Enrollment

26 participants

Start Date

Dec 15, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to evaluate the aflo™ digital platform's ability to improve inhaler use technique and asthma control for children, adolescents, and adults with uncontrolled asthma. The main questions the trial aims to answer are: 1. Does the platform improve medication adherence and inhaler technique, as measured by the Inhaler Proficiency Score (IPS)? 2. Does the aflo™ platform improve asthma control, as measured by changes in the Asthma Control Test (ACT) and lung function tests (FEV1, PEF)? Participants will: * Use the aflo™ sensor with their asthma inhaler to receive real-time feedback on technique and medication adherence reminders. * Track asthma symptoms and quality of life through a mobile app. * Complete assessment visits and surveys at the start and end of the 3-month study and 2 interim asthma assessment phone calls.


Eligibility

Min Age: 10 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an automated inhaler monitoring device that tracks when and how people use their asthma inhalers. The goal is to see if real-time feedback on inhaler use improves medication adherence and asthma control. **You may be eligible if...** - You are 12 or older (or have a child with asthma in that age range) - You have been diagnosed with asthma - You use a metered-dose inhaler (a standard asthma puffer) - Your asthma is not optimally controlled despite having an inhaler **You may NOT be eligible if...** - You do not use an inhaler for your asthma - You have severe asthma requiring frequent hospitalization in the past 3 months - You are unable to use a smartphone app to view feedback - You have COPD rather than asthma as your primary diagnosis Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICESmart Inhaler Monitoring Platform for Asthma Management

The intervention utilizes the aflo™ digital platform, a comprehensive system designed to improve asthma management through advanced technology. It integrates the following components: 1. Electronic Inhaler Sensor: The sensor attaches to a metered-dose inhaler (MDI) and a spacer (if applicable) to automate and provide feedback on the six critical steps of proper inhaler technique, such as shaking the inhaler, breathing out, inhaling slowly, and holding the breath. The sensor also records and stores medication usage data securely. 2. Mobile Application: The app delivers real-time notifications and feedback on inhaler technique, sends reminders for daily controller medication, tracks asthma symptoms, and provides monthly Asthma Control Test (ACT) assessments. It also offers reminders for spacer cleaning and customizable alerts for caregivers. 3. Clinician Portal: Data collected from the sensor and app is accessible via a secure clinician portal, enabling healthcare providers to monitor pa


Locations(1)

Boston Children's Hospital

Boston, Massachusetts, United States

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NCT06825871


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