Automated Inhaler Monitoring for Asthma Medication Usage
United States20 participantsStarted 2025-12-01
Plain-language 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.
Who can participate
Age range
10 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Youth or adult with a diagnosis of persistent asthma by a physician.
. Evidence of uncontrolled asthma as defined by an FEV1/FVC ratio of less than 80% by an asthma provider within the past 3 months, all while on controller asthma therapy.
. Females or males between the ages of 10 years and older
. Participant or caregiver must have an Apple and/or Android smart phone with operating system 4.3 or above and data plan for the duration of the study period
Exclusion criteria
. Participants with other cardiac, pulmonary with exception of asthma, neuromuscular disorders that impact breathing, or other conditions that hinder patient to perform spirometry.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial used something called an Aflo™ platform to monitor inhaler use and measured an 'Inhaler Proficiency Score' — can you explain what that score actually measures, and whether improving inhaler technique is something you think could help manage my asthma?
2Since this trial is already completed, is there any way to see the results, and do they suggest that automated inhaler monitoring made a meaningful difference for patients like me?
3This study focused specifically on how well people use their inhalers rather than testing a new medication — do you think my current inhaler technique might be a factor in how well my asthma is controlled right now?
4Are there already tools or apps similar to the Aflo™ platform available outside of a trial that you could recommend to help me track and improve my inhaler use?
5Given that this trial ran for 3 months with monitoring as its main focus, would a structured check-in approach like this fit into my current treatment plan, or is there a more pressing step we should take first?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from Baseline in the participants' Inhaler Proficiency Score (IPS) Following Aflo™ Platform Usage at 3 Month
Timeframe: From enrollment to the end of intervention period at 12 weeks
. Participants with severe neurobehavioral, neurodevelopmental, or psychiatric disorders requiring special assistance
. The participant's guardian or the patient has comprehension or language difficulties that prevent understanding of study materials (available in English) or effective training on the app or device.
. Patients are currently receiving biologic therapies for asthma management or other allergic diseases.