Digital Marker for Asthma

Overseen By Arthur H Owora, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Disqualifiers: Non-practicing pediatricians

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to enhance the diagnosis and treatment of childhood asthma using a new tool called the Childhood Asthma Passive Digital Marker (PDM). It seeks to help pediatricians identify asthma risk in children more accurately than current methods. The trial will compare pediatricians using the PDM with those who are not to determine if the tool improves asthma risk prediction. Pediatricians practicing within the IU Health Network are eligible to participate. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could transform asthma care for children.

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.

What prior data suggests that this digital marker is safe for use in childhood asthma management?

Research has shown that the Childhood Asthma Passive Digital Marker (PDM) is under study to better predict asthma risk in children. This tool analyzes information from medical records to identify children who might develop asthma. Although the PDM remains in testing, no reports indicate it causes harm, as it primarily examines existing data without involving direct medical treatment. Consequently, safety concerns are minimal, as it doesn't require medication or medical procedures. The goal is to help doctors predict and manage asthma in children more effectively. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Digital Marker for Asthma trial because it explores a new way of predicting asthma risk in children using a passive digital marker (PDM). Unlike traditional methods that rely on direct patient testing and observation, this approach leverages digital data to assess risk more efficiently and possibly more accurately. The trial could lead to early and non-invasive identification of asthma risk, allowing for timely interventions and better management of the condition. This innovative use of digital markers represents a significant shift in how clinicians might approach asthma prediction in the future.

What evidence suggests that the Childhood Asthma Passive Digital Marker is effective for predicting asthma risk?

Research shows that the Childhood Asthma Passive Digital Marker (PDM), evaluated in this trial, holds promise for predicting asthma risk in children. Studies have found the PDM to be more accurate than the traditional Pediatric Asthma Risk Score. For instance, one study examined records of nearly 70,000 children and found the PDM better at identifying which children might develop asthma. This tool uses information from electronic health records to predict asthma risk, making it practical for doctors. These findings suggest that the PDM could help doctors detect asthma earlier and manage it more effectively. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for practicing pediatricians within the IU Health Network. It aims to address underdiagnosis and undertreatment in childhood asthma by testing a new tool called a passive digital marker (PDM).

Inclusion Criteria

Practicing pediatricians within the IU Health Network

Exclusion Criteria

Non-practicing pediatricians within the IU Health Network

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Pediatric clinicians use the PDM to predict asthma risk in children based on vignettes

8 to 12 months

Follow-up

Participants are monitored for usability, feasibility, and acceptance of the PDM

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Childhood Asthma Passive Digital Marker

Trial Overview The study is evaluating the usability, acceptability, feasibility, and preliminary efficacy of a Childhood Asthma Passive Digital Marker among pediatricians.

How Is the Trial Designed?

Group I: PDM Intervention Clinicians - post test only Experimental Treatment 1 Intervention

N=25 intervention pediatric clinicians, who will receive the post test only. Using the PDM, each clinician will be presented with 10 randomly selected vignettes of 10 children \[5 with and 5 without asthma\] and asked to provide a prediction of a child's asthma risk at 6-10 years.

Group II: Control Clinicians - pre and post test Active Control 1 Intervention

N=25 control pediatric clinicians, who will receive the pre and post test. Each clinician will be presented with 10 randomly selected vignettes of 10 children \[5 with and 5 without asthma\] and asked to provide a prediction of a child's asthma risk at 6-10 years.

Group III: PDM Intervention Clinicians - pre and post test Active Control 1 Intervention

N=25 intervention pediatric clinicians, who will receive the pre and post test. Using the PDM, each clinician will be presented with 10 randomly selected vignettes of 10 children \[5 with and 5 without asthma\] and asked to provide a prediction of a child's asthma risk at 6-10 years.

Group IV: Control Clinicians - post test only Active Control 1 Intervention

N=25 control pediatric clinicians, who will receive the post test only. Each clinician will be presented with 10 randomly selected vignettes of 10 children \[5 with and 5 without asthma\] and asked to provide a prediction of a child's asthma risk at 6-10 years.

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

A study involving 90 children (60 with asthma and 30 with cystic fibrosis) demonstrated that digital biomarkers, such as physical activity, heart rate, sleep, and FEV1 measured by smartwatches and portable spirometers, can effectively capture clinical data in a home setting over 28 days.

The results indicated that these digital biomarkers could reliably reflect disease activity, with lower physical activity and FEV1 observed in patients compared to healthy children, suggesting their potential use in monitoring and managing pediatric lung diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical validation of digital biomarkers for paediatric patients with asthma and cystic fibrosis: potential for clinical trials and clinical care. Kruizinga, MD., Essers, E., Stuurman, FE., et al.[2022]

Monitoring childhood asthma should prioritize patient-centered outcomes like exacerbations and the impact on sports and play, rather than relying on surrogate measures like lung function or inflammatory markers, which are less relevant to patients.

Composite asthma control measures are limited in their usefulness for routine monitoring due to their short recall period and lack of focus on exacerbations, highlighting the need for a more personalized approach in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The clinician's guide on monitoring children with asthma. Brand, PL.[2013]

Digital technologies have been developed to improve asthma care in children and adolescents, with 70% of studies showing improved treatment adherence, indicating their potential effectiveness in supporting medication compliance.

However, the evidence for these technologies improving asthma control and health outcomes is mixed, highlighting the need for further research to understand their true impact and integration into existing healthcare systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital Technologies for Monitoring and Improving Treatment Adherence in Children and Adolescents With Asthma: Scoping Review of Randomized Controlled Trials. Milne-Ives, M., Lam, C., Meinert, E.[2021]

Ongoing monitoring is crucial for effectively managing asthma in children, but there is limited evidence on how to best integrate various monitoring components like symptoms, lung function, and inflammation.

A consensus from 22 experts highlighted the need for better tools and methods for monitoring asthma in children, as many aspects still lack sufficient evidence despite the recognized importance of monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Monitoring asthma in children. Pijnenburg, MW., Baraldi, E., Brand, PL., et al.[2022]

Research into different asthma phenotypes and endotypes in children is crucial for developing specific biomarkers that can improve diagnosis and treatment strategies.

Currently, most available biomarkers in pediatric asthma reflect type 2-high airway inflammation, but ongoing research aims to identify new noninvasive biomarkers to enhance personalized treatment approaches in childhood asthma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Asthma Endotyping and Biomarkers in Childhood Asthma. Licari, A., Castagnoli, R., Brambilla, I., et al.[2020]

Recent developments in predictive asthma scores have introduced innovative features to assess asthma risk in infants and preschool children, with 12 models identified showing varied effectiveness.

Elevated levels of fractional concentration of nitric oxide (FeNO) are a strong risk factor for asthma in early wheezers, but more research is needed to establish its reliability compared to traditional clinical scores, while specific IgE and eosinophil counts remain the most consistent biomarkers for identifying at-risk children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identification of infants and preschool children at risk for asthma: predictive scores and biomarkers. Wandalsen, GF., Solé, D., Bacharier, LB.[2018]

Asthma affects over 10% of children in Europe and North America, highlighting the need for effective diagnosis and monitoring methods, particularly through the use of non-invasive biomarkers.

The Pediatric Asthma Committee emphasizes the importance of implementing non-invasive biomarkers, such as fractional exhaled nitric oxide and spirometry, to improve asthma diagnosis and management in children, although their use in clinical practice remains limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utility of biomarkers in the diagnosis and monitoring of asthmatic children. Xepapadaki, P., Adachi, Y., Pozo Beltrán, CF., et al.[2023]

In a study of 916 preschool children, the asthma predictive index (API) was found to be a useful tool for diagnosing current asthma, showing 72.2% sensitivity and 82.0% specificity.

Despite the association with the API, the study found no significant differences in lung function tests or other asthma-related markers like airway hyperreactivity or atopic sensitization between children with and without current asthma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Asthma predictive index as a useful diagnostic tool in preschool children: a cross-sectional study in Korea. Lee, DH., Kwon, JW., Kim, HY., et al.[2020]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40496879/

External validation and update of the pediatric asthma risk ... It is feasible to use EHR data for childhood asthma risk prediction by updating existing tools (eg, PARS) with relevant clinical context to assure high ...

2. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-5370(25)00186-5/fulltext

External validation and update of the pediatric asthma risk ... This study demonstrates that it is feasible to use electronic health records (EHR) data to develop a passive digital marker (PDM) for childhood asthma risk ...

3. regenstrief.org regenstrief.org/article/digital-marker-improve-childhood-asthma-detection/

New digital marker could improve childhood asthma ... The findings revealed the new passive digital marker was more accurate than the traditional Pediatric Asthma Risk Score in predicting which ...

4. medicine.iu.edu medicine.iu.edu/news/2025/06/childhood-asthma-digital-marker-early-detection

New digital marker could improve childhood asthma detection The findings revealed the new passive digital marker was more accurate than the traditional Pediatric Asthma Risk Score in predicting which ...

5. aarc.org aarc.org/news/featured-buzz-june-30-25/

Featured Buzz June 30, 2025 The study, which involved records on nearly 70,000 kids, found the passive digital marker was more accurate in predicting which children would ...

6. reporter.nih.gov reporter.nih.gov/search/B5qeHaxU-0Gxi3237HAmqg/project-details/10571461

Developing a Childhood Asthma Risk Passive Digital Marker Owora's ongoing prognostic research to: (1) develop and evaluate the predictive performance of a childhood asthma PDM, compared to a Pediatric Asthma Risk Score ...