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Active, not recruitingNCT06389058Updated Apr 22, 2026

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

An observational study in Severe Asthma, sponsored by San Diego State University. Active, not recruiting at 1 site in United States. Open to participants aged 6 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-04-22.

Sponsored by San Diego State University · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
31,795
Ages
6 Years to 85 Years
Sex
All
01

Study summary

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.
Read the detailed description

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.
02

Conditions studied

  • Severe Asthma

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03

In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

This study's enrollment of 31,795 is above the median of 150 across 970 observational studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

San Diego State University is the lead sponsor of 145 studies on the registry; 41 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

De-identified EHR data from N=31,795 patients diagnosed with asthma at Scripps Health (San Diego, CA) were filtered and processed, adhering to strict inclusion and exclusion criteria designed to accurately isolate cases of asthma.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • None
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
31,795 participants (actual)
Target follow-up
2 Years
Patient registry
Yes

Groups and cohorts

  • Severe Asthma

    Patients with Severe or Uncontrolled Asthma

    Other: Recommendation for the diagnoses and treatment of Severe Asthma

Interventions

  • OtherRecommendation 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.

06

What researchers measure

Primary outcomes

  1. Identification of Patients with Severe Asthma

    Identify patients with severe asthma and compare diagnoses to that of medical professionals

    Time frame: 4 years

07

Study locations

1 site
  • San Diego State University
    San Diego, California 92182-1309, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06389058
Lead sponsor
San Diego State University
Collaborators
GlaxoSmithKline, Scripps Health, Modena Allergy + Asthma, La Jolla, CA, University of California, San Diego
Responsible party
Sponsor
First posted
Apr 29, 2024
Start date
May 1, 2023
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Apr 22, 2026

Study contacts

yusuf Ozturk, Ph.D.
principal investigator · San Diego State University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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