Medication Monitoring for Adolescent Asthma

Overseen By Heather EH De Keyser, MD MS

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Must be taking: Inhaled controller, Rescue medication

Disqualifiers: Cystic fibrosis, Developmental delay, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial studies how teens with asthma take their medications using an electronic monitor. The goal is to better understand medication habits and improve management by sharing this information with participants, their guardians, and doctors. Participants must have asthma and use specific inhaled medications. The trial seeks teens with regular asthma treatment routines who may find it challenging to adhere consistently. As an unphased study, this trial offers a unique opportunity for participants to contribute to research that could enhance asthma management for teens.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it seems you need to be on certain asthma medications to participate.

What prior data suggests that this medication monitoring is safe for adolescents?

A previous study showed that electronic monitoring devices help people adhere better to their asthma medication routines, improving asthma management. However, limited information exists on how these devices specifically benefit teenagers. Another review examined medication adherence in children and teens, finding that, on average, they do not take their asthma medicine as often as recommended, indicating room for improvement.

Electronic medication monitors do not involve new drugs or treatments, making them very safe. These devices track inhaler usage and share this information with the user and their caregivers. No evidence suggests harmful effects from using these monitors. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new way of monitoring medication use in teens with asthma. Unlike standard treatments that focus on medication prescriptions and adherence without direct feedback, this approach uses a smartphone app and a portal to provide real-time insights into medication usage patterns. This innovative method aims to empower patients and their guardians with better information, potentially leading to more informed and consistent medication use. By understanding patients' perceptions and barriers to medication adherence, researchers aim to find new ways to support effective asthma management.

What evidence suggests that medication monitoring is effective for adolescent asthma?

Research has shown that electronic medication monitoring, which participants in this trial will experience, can help teenagers with asthma take their medicine more regularly. One study found that a monitoring device reduced missed doses to 26% after four weeks and further to 22% after eight weeks. Reviews of these electronic monitoring devices (EMDs) confirm their effectiveness in helping children and teenagers adhere to their medication schedules. These devices enable both patients and caregivers to track medication use, leading to better asthma management. Overall, electronic monitoring offers a promising method for young people to manage their asthma more effectively. ^{3 4 6 7 8}

Who Is on the Research Team?

Heather EH De Keyser, MD MS

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

This trial is for adolescents with asthma who are using both a controller and rescue inhaler compatible with an electronic monitor. They must have been diagnosed with asthma and be able to communicate in English, Spanish, Catalan, Dutch, French, German or Italian. Those with tracheostomy, interstitial lung disease, significant developmental delays or other serious chronic lung conditions like cystic fibrosis aren't eligible.

Inclusion Criteria

I have been diagnosed with asthma.

I use an inhaler that can be monitored with a Propeller device.

Exclusion Criteria

I have interstitial lung disease.

I have long-term breathing problems.

You have a major delay in your development.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants' medication use is monitored using an electronic medication monitoring platform for one year

12 months

Continuous monitoring via electronic platform

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Medication Monitoring

Trial Overview

The study aims to understand how well adolescents follow their prescribed asthma treatment by using an electronic device that monitors medication usage.

How Is the Trial Designed?

Group I: Cohort Experimental Treatment 1 Intervention

Participants will be enrolled in medication use monitoring. Their medication use patterns will be available to themselves and their guardians via a smartphone application, and to their asthma care providers via a portal. There will be no interventions to change medication use patterns. A portion of them will be asked to participate in a semistructured interview during which they will be asked questions about their perception of their asthma, health beliefs regarding medication use, and what they feel would be the most helpful to get them to take their asthma medicines. Additionally a small group of healthcare providers will be asked to participate in a focus group to collect qualitative data on medication use barriers and facilitators

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Published Research Related to This Trial

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 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]

From 2000 to 2016, the incidence of adverse drug events related to anti-asthmatic medications in hospitalized children increased significantly, from 5.3 to 21.6 per 1000 discharges, indicating a growing concern for safety in pediatric asthma treatment.

Children aged 0-4 years experienced the most dramatic rise in adverse events from bronchodilators, highlighting the need for careful monitoring and management of asthma medications in this vulnerable age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Drug Events Related to Common Asthma Medications in US Hospitalized Children, 2000-2016. Xie, L., Gelfand, A., Mathew, MS., et al.[2022]

An estimated 158,520 children and adolescents visit emergency departments annually due to adverse drug events (ADEs), with nearly half of these cases occurring in children aged 1 to 4 years.

Unintentional overdoses are the most common cause of these ADEs, highlighting the need for targeted interventions to prevent such incidents, especially for medications frequently prescribed to young children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

National surveillance of emergency department visits for outpatient adverse drug events in children and adolescents. Cohen, AL., Budnitz, DS., Weidenbach, KN., et al.[2018]

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7483778/

The Efficacy of a Novel Monitoring Device on Asthma ...

This improvement was observed at 4 weeks with rates down to 26% and further reduced to 22% at 8 weeks and it remained improved until final visit (Figure 1).

2.

onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/10.1002/ppul.71355?af=R

Systematic Review of Electronic Monitoring to Increase ...

This systematic review examines the outcomes, feasibility, and effective features of EMDs for children and adolescents with asthma, providing ...

3.

ejb.springeropen.com

ejb.springeropen.com/articles/10.1186/s43168-024-00336-4

Evaluating adherence and inhaler monitoring among ...

Adherence promotion interventions have been proven effective among patients with asthma. Electronic monitoring modalities have demonstrated superiority and ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10538420/

Encouraging Adherence in Adolescents with Asthma Using ...

The objective of this study was to test if a modest financial incentive improved medication adherence in adolescents with asthma compared with a control group.

5.

respiratory-research.biomedcentral.com

respiratory-research.biomedcentral.com/articles/10.1186/s12931-024-02817-y

Objective monitoring tools for improved management of ...

A cohort study showed that spirometry detected 54% of abnormal results in children who reported good asthma symptom control [42]. This ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6969681/

Treatment Adherence in Adolescents with Asthma - PMC

According to a review of pediatric asthma studies using electronic adherence monitoring, mean adherence rates are largely below 75%, while as ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7739079/

Medication Errors in Adolescents Using Asthma Controller ...

About 38% of adolescents reported 1 error in using asthma controller medications, 16% reported 2 errors, and 5% reported 3 or more errors. About 42% of ...

8.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07129616

Remote Monitoring of Asthma in Children and Young People

The objective of this study is to determine whether healthcare data and remotely collected patient data can accurately predict asthma attacks in children ...