Automated Inhaler Monitoring for Asthma Medication Usage

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 10
Healthy Volunteers: f
View:

• 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

Locations
United States
Massachusetts
Boston Children's Hospital
RECRUITING
Boston
Contact Information
Primary
Wanda Phipatanakul, MD
Asthma@childrens.harvard.edu
857-218-5336
Time Frame
Start Date: 2025-12-15
Estimated Completion Date: 2026-06
Participants
Target number of participants: 26
Treatments
Experimental: 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.
Related Therapeutic Areas
Sponsors
Collaborators: Respiratory Analytics Ltd
Leads: Boston Children's Hospital

This content was sourced from clinicaltrials.gov