Automated Inhaler Monitoring for Asthma Medication Usage
NCT ID: NCT06825871
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
26 participants
INTERVENTIONAL
2025-12-31
2026-06-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Intervention group
Participants will use the aflo™ digital platform, which includes an electronic inhaler sensor, a mobile application, and a clinician portal. The platform provides real-time feedback on inhaler technique and sends medication reminders to improve adherence. Participants will also receive daily symptom tracking prompts and monthly Asthma Control Test (ACT) assessments.
During the study, participants will:
* Attach the aflo™ sensor to their metered-dose inhaler (MDI) and use it with or without a spacer, based on their prescribed regimen.
* Complete at least one supervised inhalation session during the baseline visit to ensure proper use of the sensor.
* Use the aflo™ mobile app to log asthma symptoms, medication usage, and track reminders.
* Participate in two clinic visits (at baseline and study completion) and two follow-up phone calls (at weeks 4 and 8) to monitor progress.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
2. 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
3. Females or males between the ages of 10 years and older
4. 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
2. Participants with severe neurobehavioral, neurodevelopmental, or psychiatric disorders requiring special assistance
3. 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.
4. Patients are currently receiving biologic therapies for asthma management or other allergic diseases.
10 Years
ALL
No
Sponsors
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Respiratory Analytics Ltd
UNKNOWN
Boston Children's Hospital
OTHER
Responsible Party
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Wanda Phipatanakul
S. Jean Emans, MD, Professor of Pediatrics at Harvard Medical School
Locations
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Boston Children's Hospital
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Wanda Phipatanakul
Role: primary
Other Identifiers
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P00049452
Identifier Type: -
Identifier Source: org_study_id