AeviceMD for Pediatric Asthma

(APAM Trial)

Overseen By Bobby Marker

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Irina Dralyuk

Disqualifiers: Allergy to silicone, Sleep apnea, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

20 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your current asthma treatments while using the AeviceMD device, but please confirm with the trial coordinators.

Is AeviceMD safe for children with asthma?

The safety of asthma medications in children has been studied, and while adverse events (unwanted side effects) can occur, these reports help identify rare and serious reactions. However, specific safety data for AeviceMD itself is not mentioned in the available research. ^{1 2 3 4 5}

What is the purpose of this trial?

A wearable remote patient monitor (AeviceMD) is to be used to monitor the respiratory health of pediatric asthma patients in this pilot study. Patients prescribed with AeviceMD should be able to gain better control over their disease during home management. Physicians should be able to optimize treatment for these patients using objective data collected from and of these patients outside of the clinic. The AeviceMD should also be used as a remote auscultation device for teleconsultations.

Research Team

Irina Dralyuk, MD

Principal Investigator

Cedars-Sinai Medical Center

Eligibility Criteria

This trial is for children with asthma. Participants should be currently managing their asthma and looking to improve control over the disease at home. They must be willing to use AeviceMD, a wearable monitor, as part of their treatment plan.

Inclusion Criteria

Asthma control test score below

Caregiver able to operate a mobile application

My asthma is not well-managed.

Exclusion Criteria

I have been diagnosed with sleep apnea.

Known allergy to silicone, gold, or zinc

I have skin issues on my chest.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the AeviceMD device for continuous monitoring of vital signs and wheezing detection during night sleep

12 weeks

Baseline and final in-person visits, teleconsultations

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• AeviceMD

Trial Overview The study tests AeviceMD, a wearable device designed to monitor respiratory health in kids with asthma. It aims to help patients manage their condition better at home and provide doctors with data for optimizing treatment.

Participant Groups

Group I: AeviceMD Experimental Treatment 1 Intervention

This is a single site, single arm, open label medical device (AeviceMD) pilot where only intervention groups will be recruited.

Who Is Running the Clinical Trial?

Irina Dralyuk

Lead Sponsor

Trials

1

Recruited

20+

AEvice Health Pte Ltd

Collaborator

Trials

2

Recruited

60+

Aevice Health Pte. Ltd.

Collaborator

Trials

3

Recruited

220+

Findings from Research

A comprehensive analysis of 372,345 spontaneous reports from 2011 to 2017 identified 385 different safety signals related to asthma medications in children, with a notable focus on psychiatric events, highlighting the importance of monitoring these drugs in the pediatric population.

The study uncovered new safety signals, such as herpes viral infections linked to omalizumab and hypertrichosis associated with budesonide, emphasizing that age stratification is crucial for detecting unique risks in children that may not be evident in the broader population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploratory Study of Signals for Asthma Drugs in Children, Using the EudraVigilance Database of Spontaneous Reports. Baan, EJ., de Smet, VA., Hoeve, CE., et al.[2021]

A review of 326 spontaneous adverse drug reaction reports for asthma medications in children revealed that approximately 85% of these reports were serious, including six fatal cases, highlighting significant safety concerns.

The most commonly reported adverse reactions were psychiatric disorders (13%), respiratory issues (10%), and skin disorders (9%), with budesonide, salbutamol, and fluticasone being the medications with the highest number of reported ADRs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Paediatric adverse drug reactions following use of asthma medications in Europe from 2007 to 2011. Aagaard, L., Hansen, EH.[2021]

A systematic review of 46 studies on pediatric asthma medications revealed that inhaled corticosteroids (ICS) are associated with 174 adverse drug events (ADE), including potential issues like adrenal and growth suppression.

Serious adverse drug events were rare, occurring in 0.9-6% of cases, and there were no confirmed deaths in pediatric patients, although methodological concerns were noted regarding the identification and assessment of ADE in the studies reviewed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of adverse drug events associated with administration of common asthma medications in children. Leung, JS., Johnson, DW., Sperou, AJ., et al.[2022]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Exploratory Study of Signals for Asthma Drugs in Children, Using the EudraVigilance Database of Spontaneous Reports. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Safety of corticosteroids in young children with acute respiratory conditions: a systematic review and meta-analysis. [2020]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Paediatric adverse drug reactions following use of asthma medications in Europe from 2007 to 2011. [2021]

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

A systematic review of adverse drug events associated with administration of common asthma medications in children. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Incidence and characteristics of adverse events in paediatric inpatient care: a systematic review and meta-analysis. [2023]