Automated Inhaler Monitoring for Asthma Medication Usage (AIM)

  • STATUS
    Recruiting
  • days left to enroll
    85
  • participants needed
    26
  • sponsor
    Boston Children's Hospital
Updated on 20 March 2026

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.

Details
Condition Asthma
Age 10years or above
Clinical Study IdentifierNCT06825871
SponsorBoston Children's Hospital
Last Modified on20 March 2026

Eligibility

Yes No Not Sure

Inclusion Criteria

Youth or adult with a diagnosis of persistent asthma by a physician
Evidence of uncontrolled asthma as defined by an ACT score of less than 19 AND 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
Patients are currently receiving biologic therapies for asthma management or other allergic diseases
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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