Clinical Trial

Automated Inhaler Monitoring for Asthma Medication Usage

Study acronym: AIM
Completed
View on ClinicalTrials.gov →
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.
Protocol Amendment History 5 changes
critical Trial completed 2026-07-30
notable Enrollment reduced: 26 -> 20 participants 2026-07-30
critical Trial status changed: Recruiting → Active, Not Recruiting 2026-04-09
notable Primary completion pushed: 2026-03 -> 2026-07 2026-04-09
minor Completion pushed: 2026-06 -> 2026-07 2026-04-09
Trial Details
NCT Number NCT06825871
Lead Sponsor Boston Children's Hospital
Collaborators: Respiratory Analytics Ltd
Conditions Asthma
Enrollment 20 participants
Start Date 2025-12-01
Primary Completion 2026-06-26 (estimated)
Study Completion 2026-06-26 (estimated)
Updated on ClinicalTrials.gov 2026-07-29