NCT06825871

Automated Inhaler Monitoring for Asthma Medication Usage

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (estimated)
• Sponsor: Boston Children's Hospital · Academic / Other
• Sex: All
• Age: 10 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Asthma

Interventions

Type	Name	Description
DEVICE	Smart 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

Timeline

• Start date: 2025-12-01
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2025-02-13
• Last updated: 2026-04-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study