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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a smart inhaler monitoring platform to determine if it helps people with asthma use their inhalers more effectively and maintain better asthma control. The study will assess whether the platform improves the frequency and accuracy of inhaler use and aids in managing asthma symptoms by tracking them over time through an app. It suits individuals aged 10 and older with persistent, poorly controlled asthma who own a smartphone for use during the study. Participants will attach a sensor to their inhaler, receive real-time feedback, and track their symptoms via a mobile app. As an unphased trial, this study offers a unique opportunity to contribute to innovative asthma management solutions.

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 prior data suggests that this smart inhaler monitoring platform is safe for asthma patients?

Research shows that digital inhaler tools like aflo™ are generally safe and easy to use. Studies have found that these tools can improve quality of life and help manage asthma. No serious safety issues have been reported.

The aflo™ tool does not dispense medicine. Instead, it aids in correct inhaler use by providing real-time feedback and reminders. Since it focuses on proper inhaler use, it is unlikely to cause side effects.

In summary, the aflo™ digital tool has been used safely in other studies and is designed to support, not replace, the current inhaler routine. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Smart Inhaler Monitoring Platform because it uses advanced technology to enhance asthma management. Unlike traditional treatments that rely solely on medication, this platform includes an electronic inhaler sensor and a mobile app that provide real-time feedback on inhaler use and send medication reminders. This helps improve adherence and technique, which are critical for effective asthma control. Additionally, the platform offers daily symptom tracking and monthly assessments, empowering users to actively manage their condition and potentially reduce asthma-related complications.

What evidence suggests that the Smart Inhaler Monitoring Platform is effective for improving asthma control?

Research has shown that digital inhaler platforms can greatly improve asthma control. One study found that people using a digital inhaler system were 85.3% more likely to achieve better asthma control compared to those who did not use it. Another study demonstrated that users needed their rescue inhalers 39% less often, indicating fewer asthma symptoms. Additionally, digital health tools for asthma care have been linked to lower healthcare costs by reducing the need for extra treatments. In this trial, participants in the intervention group will use the aflo™ smart inhaler monitoring platform, which could enhance asthma management by ensuring correct and regular inhaler use. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12334831/

The evolving landscape of digital inhaler platforms and ... Across 10 studies in asthma or COPD, seven reported improvements in HRQoL, and six documented reductions in lung function decline and or ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2213219822008285

Effectiveness of a Digital Inhaler System for Patients With ... In this study, participants using the RDS were found to have an 85.3% probability of achieving greater odds of improvement in asthma control than those using ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06825871?cond=Inhaler&lastUpdPost=2020-07-15_&viewType=Table&rank=7

Automated Inhaler Monitoring for Asthma Medication Usage 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 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6917046/

Mobile Health and Inhaler-Based Monitoring Devices for ... An additional study of 120 participants enrolled in a single-arm trial of the Propeller Health digital platform found that SABA use dropped by 39%, and symptom- ...

5. jaci-inpractice.org jaci-inpractice.org/article/S2213-2198(21)00233-6/fulltext

Digital Health Technology in Asthma A smart nebulizer system was associated with decreased costs of additional treatments associated with asthma, such as antibiotics and ...

6. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06825871

Automated Inhaler Monitoring for Asthma Medication Usage Use the aflo™ sensor with their asthma inhaler to receive real-time feedback on technique and medication adherence reminders. Track asthma symptoms and quality ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S152605422500079X

Smart inhalers in paediatric asthma: bridging the gap ... Stand-alone smart inhalers offer digital support to improve medication adherence and self-management, inhaler technique, and medical decision ...

8. emjreviews.com emjreviews.com/respiratory/article/opportunities-and-challenges-in-the-implementation-of-smart-inhalers-to-improve-asthma-outcomes-j160123/

Opportunities and Challenges in the Implementation ... - EMJ Aligning smart inhaler data with FeNO, spirometry, and symptoms can effectively identify the population with difficult-to-treat asthma who can ...

9. publications.ersnet.org publications.ersnet.org/content/erjor/11/5/01178-2024

Enhancing severe asthma care: real-world outcomes of a ... b) Patient outcomes after 6 months of using the Propeller digital platform. Outcome data presented for the 44 patients who used the Propeller digital platform ...