Automated Inhaler Monitoring for Asthma Medication Usage
United States26 participantsStarted 2025-12-01
Plain-language summary
The goal of this clinical trial is to evaluate the afloâ„¢ 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 afloâ„¢ platform improve asthma control, as measured by changes in the Asthma Control Test (ACT) and lung function tests (FEV1, PEF)?
Participants will:
* Use the afloâ„¢ 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 range10 Years
SexALL
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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.
✕. 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.
✕
What they're measuring
1
Change from Baseline in the participants' Inhaler Proficiency Score (IPS) Following Afloâ„¢ Platform Usage at 3 Month
Timeframe: From enrollment to the end of intervention period at 12 weeks