Using NLP and Neural Networks to Autonomously Identify Severe Asthma and Determine Study Eligibility in a Large Healthcare System

NCT ID: NCT06389058

Last Updated: 2025-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

31795 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-01

Study Completion Date

2026-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The study aims to to use new technologies (ML, AI, NLP), to autonomously identify moderate to severe asthma populations within an EHR system, describe differences in treatment patterns across different populations, and determine trial eligibility.

Primary Objectives Please ensure you detail primary objectives Aim 1. Determine and validate a diagnosis of severe asthma (SA) using predictive features obtained from the Scripps Health EHR.

* Aim 1a: Use ML applied to structured EHR data to predict SA. Use the opinion of 2 specialty-trained physicians and ATS guidelines to determine model accuracy.
* Aim 1b: Use NLP applied to unstructured text to predict SA. Determine model accuracy as above in Aim 1a.
* Aim 1c: Use a combination of ML applied to structured data to predict SA. Determine model accuracy as above in Aim 1a.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Asthma is a heterogeneous disease. The heterogeneity of asthma is supported by clinical observations and genome wide association studies (GWASs) that have identified over 200 asthma susceptibility loci in the DNA. These genetic 'hot spots' are near inflammatory cytokines, growth factors, and other inflammatory proteins knowingly linked to airway inflammation, including cytokines IL-4, -5, -13, -25, -33, and TSLP.

Novel monoclonal antibody therapies have drastically changed the treatment of moderate-to-severe asthma. Novel monoclonal antibody therapies introduced in the last 7 years have greatly advanced treatment options for moderate-to-severe asthma patients. These therapies effectively reduce or eliminate severe exacerbations, prevent hospitalizations, and improve patients' quality of life. However, many severe asthma patients, particularly those living in underserved areas, are still being overtreated with steroids and undertreated with monoclonal antibodies.

The 21st Century Cures Act will Change the Landscape of Research. The 21st Century Cures Act reinforced the use of real-world data (RWD) and real-world evidence (RWE) to support clinical trials, aid in drug coverage decisions, develop national treatment guidelines as well as standardized decision support tools. An underutilized source of RWE/D are electronic health records (EHR). Machine Learning (ML), AI, and natural language processing (NLP) are developing technologies that will greatly advance our ability to leverage data in EHR systems.

The study aims to use new technologies (ML, AI, NLP), to autonomously identify moderate to severe asthma populations within an EHR system, describe differences in treatment patterns across different populations, and determine trial eligibility.

Primary Objectives Please ensure you detail primary objectives Aim 1. Determine and validate a diagnosis of severe asthma (SA) using predictive features obtained from the Scripps Health EHR.

* Aim 1a: Use ML applied to structured EHR data to predict SA. Use the opinion of 2 specialty-trained physicians and ATS guidelines to determine model accuracy.
* Aim 1b: Use NLP applied to unstructured text to predict SA. Determine model accuracy as above in Aim 1a.
* Aim 1c: Use a combination of ML applied to structured data to predict SA. Determine model accuracy as above in Aim 1a.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Severe Asthma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Severe Asthma

Patients with Severe or Uncontrolled Asthma

Recommendation for the diagnoses and treatment of Severe Asthma

Intervention Type OTHER

No intervention planned in this phase for the patients. Recommendations to be developed for healthcare and condition.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Recommendation for the diagnoses and treatment of Severe Asthma

No intervention planned in this phase for the patients. Recommendations to be developed for healthcare and condition.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

\- Demographics: Males \~ 40%, Blacks \~ 5-10%, Hispanic \~15-30%, Urban \~80-90%

Exclusion Criteria

* None
Minimum Eligible Age

6 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

Scripps Health

OTHER

Sponsor Role collaborator

Modena Allergy + Asthma, La Jolla, CA

UNKNOWN

Sponsor Role collaborator

University of California, San Diego

OTHER

Sponsor Role collaborator

San Diego State University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

yusuf Ozturk, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

San Diego State University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

San Diego State University

San Diego, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

G00014538

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

National Survey on Asthma
NCT00770250 COMPLETED
Treatable Traits of Severe Asthma
NCT06811740 ENROLLING_BY_INVITATION NA