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

120 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will evaluate how adolescents take their asthma medications using an electronic medication monitor.

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 data supports the effectiveness of the treatment Medication Monitoring for adolescent asthma?

Research shows that using electronic monitoring and feedback can help children with asthma stick to their medication schedules better. This approach has been found to improve adherence, meaning kids are more likely to take their medicine as prescribed, which can lead to better asthma control. ^{1 2 3 4 5}

Is the treatment generally safe for humans?

Research on asthma medications for children shows that while adverse drug events (unwanted side effects) can occur, they are often monitored through reports and studies to ensure safety. These studies help identify any serious or rare reactions, contributing to a better understanding of the safety of these medications in young people. ^{6 7 8 9 10}

How is the treatment in the Medication Monitoring for Adolescent Asthma trial different from other asthma treatments?

This treatment is unique because it uses electronic medication monitoring (EMM) to track daily medication use, which helps improve adherence to asthma medications in adolescents. Unlike traditional treatments, this approach provides real-time feedback and data on medication usage, potentially leading to better asthma control and fewer exacerbations. ^{1 2 3 11 12}

Research Team

Heather EH De Keyser, MD MS

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

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

Electronic monitoring and feedback to improve adherence in pediatric asthma. [2021]

2. Canada pubmed.ncbi.nlm.nih.gov

Parent Experiences With Electronic Medication Monitoring in Pediatric Asthma Management: Qualitative Study. [2022]

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

Electronic adherence monitoring devices for children with asthma: A systematic review and meta-analysis of randomised controlled trials. [2021]

4. England pubmed.ncbi.nlm.nih.gov

"I just forget to take it": asthma self-management needs and preferences in adolescents. [2022]

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

Providing feedback on adherence increases use of preventive medication by asthmatic children. [2017]

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

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

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

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

8. Switzerland pubmed.ncbi.nlm.nih.gov

Adverse Drug Events Related to Common Asthma Medications in US Hospitalized Children, 2000-2016. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

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

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

National surveillance of emergency department visits for outpatient adverse drug events in children and adolescents. [2018]

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

Outpatient management of asthma in children. [2021]

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

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