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Automated Inhaler Monitoring for Asthma Medication Usage

NCT06825871 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2026-04-08

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-01
Primary Completion
2026-07-31
Completion
2026-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06825871 on ClinicalTrials.gov