Automated Inhaler Monitoring for Asthma Medication Usage

NCT06825871 | Active Not Recruiting FDA Device

• 1 other identifier: P00049452
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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:

• 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.

Conditions

Asthma

Keywords

Asthma; Inhalers; Quality Control; Digital Health

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in the participants' Inhaler Proficiency Score (IPS) Following Aflo™ Platform Usage at 3 Month

  Inhaler Proficiency Score (IPS) is a validated, composite score that assesses the accuracy and consistency of inhaler technique, including steps such as inhaler preparation, actuation timing, inhalation depth, and breath hold. Scores range from 0 to 10, with higher scores indicating greater inhaler technique proficiency. Scores will be recorded at baseline and again after 3 months of using the Aflo™ digital platform, which provides step-by-step guidance and real-time feedback on inhaler technique. The outcome measure reflects the mean change in IPS from baseline to the 3-month follow-up to evaluate the effectiveness of the intervention.

  From enrollment to the end of intervention period at 12 weeks

Secondary Outcomes (2)

• Evaluation of the aflo™ Platform for Improving Asthma Control Using ACT Scores

  From enrollment to the end of intervention period at 12 weeks

• Impact of the aflo™ Platform on Health-Related Quality of Life and Clinical Outcomes in Asthma

  From enrollment to the end of intervention period at 12 weeks

Study Arms (1)

Intervention group

EXPERIMENTAL

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.

Device: Smart Inhaler Monitoring Platform for Asthma Management

Interventions

Smart Inhaler Monitoring Platform for Asthma Management DEVICE

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

Intervention group

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Children's Hospital: lead
• Respiratory Analytics Ltd: collaborator

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: S. Jean Emans, MD, Professor of Pediatrics at Harvard Medical School

Study Record Dates

• First Submitted: February 8, 2025
• First Posted: February 13, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)