Smart Inhaler Monitoring for Asthma

(AIM Trial)

Overseen By Wanda Phipatanakul, MD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Boston Children's Hospital

Must be taking: Controller therapies

Must not be taking: Biologic therapies

Disqualifiers: Cardiac, Pulmonary, Neuromuscular, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

26 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to evaluate the aflo™ digital platform's ability to improve asthma control and inhaler technique for children, adolescents, and adults with uncontrolled asthma. The main questions the trial aims to answer are: 1. Does the aflo™ platform improve asthma control, as measured by changes in the Asthma Control Test (ACT) and lung function tests (FEV1, PEF)? 2. Does the platform improve medication adherence and inhaler technique, as measured by the Inhaler Proficiency Score (IPS)? 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 assessments and surveys at the start and end of the 3-month study and 2 interim asthma assessment phone calls.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants must have uncontrolled asthma while on controller therapies, so you may need to continue your current asthma medications.

What data supports the effectiveness of the Smart Inhaler Monitoring Platform treatment for asthma?

Research shows that electronic inhaler monitoring can improve patient adherence to asthma medication, which is crucial for better disease control and reducing hospital visits. The Smart Inhaler has been found to accurately track medication use, helping healthcare providers monitor and personalize treatment for better outcomes. ^{1 2 3 4 5}

Is the Smart Inhaler Monitoring Platform safe for humans?

The Smart Inhaler Monitoring Platform has been tested for accuracy and reliability in recording inhaler use, and no safety concerns have been reported in the studies available. It is primarily used to monitor medication adherence in asthma patients. ^{1 2 3 6 7}

How is the Smart Inhaler Monitoring Platform treatment different from other asthma treatments?

The Smart Inhaler Monitoring Platform is unique because it uses digital technology to track medication use and adherence, providing real-time data to both patients and healthcare providers. This helps ensure that patients are using their inhalers correctly and consistently, which can improve asthma management and outcomes. ^{1 2 4 7 8}

Eligibility Criteria

This trial is for children, adolescents, and adults with uncontrolled asthma. Participants will use a smart inhaler monitoring platform to help manage their condition. They must be willing to track symptoms and quality of life through an app and complete assessments throughout the 3-month study.

Inclusion Criteria

I have been diagnosed with persistent asthma.

I am at least 10 years old.

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 documented developmental delays or impairments that would interfere with ability to use aflo™ system

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

I have a condition affecting my breathing but not asthma.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete a supervised inhalation session and baseline assessments

1 day

1 visit (in-person)

Treatment

Participants use the aflo™ digital platform for asthma management, including real-time feedback and medication reminders

12 weeks

2 visits (in-person), 2 phone calls

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Smart Inhaler Monitoring Platform

Trial Overview The aflo™ digital platform is being tested for its effectiveness in improving asthma control and inhaler technique. The study measures changes in Asthma Control Test scores, lung function tests (FEV1, PEF), medication adherence, and proficiency in using an inhaler.

Participant Groups

Group I: Intervention group Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Boston Children's Hospital

Lead Sponsor

Trials

801

Recruited

5,584,000+

Respiratory Analytics Ltd

Collaborator

Trials

1

Recruited

30+

Findings from Research

The study involved 1306 quality control tests of an electronic monitoring device for asthma inhalers, showing a high reliability rate of 84% for pre-issue tests and 87% for return tests, although some devices had issues with under-recording.

Children using the device with reminder features reported significantly higher acceptability scores compared to those without reminders, with over 90% finding the device easy to use, indicating strong potential for improving asthma management in this age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic adherence monitoring device performance and patient acceptability: a randomized control trial. Chan, AHY., Stewart, AW., Harrison, J., et al.[2018]

The study introduces a cloud-based wearable IoT aldehyde sensor system designed to monitor environmental factors that can trigger asthma, potentially improving asthma management.

This innovative sensor system allows for real-time data collection and analysis, which can help researchers and patients better understand and manage asthma triggers in their daily environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Wearable IoT Aldehyde Sensor for Pediatric Asthma Research and Management. Li, B., Dong, Q., Downen, RS., et al.[2020]

References

1. England pubmed.ncbi.nlm.nih.gov

Electronic adherence monitoring device performance and patient acceptability: a randomized control trial. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Advances in Audio-Based Systems to Monitor Patient Adherence and Inhaler Drug Delivery. [2022]

3. England pubmed.ncbi.nlm.nih.gov

In vitro evaluation of an asthma dosing device: the smart-inhaler. [2006]

4. Switzerland pubmed.ncbi.nlm.nih.gov

A Wearable IoT Aldehyde Sensor for Pediatric Asthma Research and Management. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Electronic Inhaler Monitoring for Chronic Airway Disease: Development and Application of a Multidimensional Efficacy Framework. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Assessing adherence to inhaled therapies in asthma and the emergence of electronic monitoring devices. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Use of metered-dose inhaler electronic monitoring in a real-world asthma randomized controlled trial. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

The Digital Asthma Patient: The History and Future of Inhaler Based Health Monitoring Devices. [2022]