Clinical trial NCT06825871: Automated Inhaler Monitoring for Asthma Medication Usage
Official title: Automated Inhaler Monitoring for Asthma Medication Usage
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Asthma
Keywords: Asthma
Inhalers
Quality Control
Digital Health
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: Respiratory Analytics Ltd
First posted: 2025-02-13
Enrollment: 26
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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:

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 criteria: Inclusion Criteria:

1. Youth or adult with a diagnosis of persistent asthma by a physician.
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:

1. Participants with other cardiac, pulmonary with exception of asthma, neuromuscular disorders that impact breathing, or other conditions that hinder patient to perform spirometry.
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.

Primary outcomes:
measure: Change from Baseline in the participants' Inhaler Proficiency Score (IPS) Following Aflo™ Platform Usage at 3 Month
timeFrame: From enrollment to the end of intervention period at 12 weeks
Secondary outcomes:
measure: Evaluation of the aflo™ Platform for Improving Asthma Control Using ACT Scores
timeFrame: From enrollment to the end of intervention period at 12 weeks
measure: Impact of the aflo™ Platform on Health-Related Quality of Life and Clinical Outcomes in Asthma
timeFrame: From enrollment to the end of intervention period at 12 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
References: