Automated Inhaler Monitoring for Asthma Medication Usage
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Boston Children's Hospital
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Change from Baseline in the participants' Inhaler Proficiency Score (IPS) Following Aflo™ Platform Usage at 3 Month
Study Overview
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:
- Does the platform improve medication adherence and inhaler technique, as measured by the Inhaler Proficiency Score (IPS)?
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 10 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
- •Patients are currently receiving biologic therapies for asthma management or other allergic diseases.
Arms & Interventions
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.
Intervention: Smart Inhaler Monitoring Platform for Asthma Management (Device)
Outcomes
Primary Outcomes
Change from Baseline in the participants' Inhaler Proficiency Score (IPS) Following Aflo™ Platform Usage at 3 Month
Time Frame: From enrollment to the end of intervention period at 12 weeks
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.
Secondary Outcomes
- 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)
Investigators
Wanda Phipatanakul
S. Jean Emans, MD, Professor of Pediatrics at Harvard Medical School
Boston Children's Hospital