RecruitingNCT07223749

Validation of Chronic Obstructive Pulmonary Disease (COPD) Algorithm

Validation of a Chronic Obstructive Pulmonary Disease (COPD) Predictive Algorithm


Sponsor

Wake Forest University Health Sciences

Enrollment

500 participants

Start Date

Aug 22, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

Under-diagnosis of Chronic Obstructive Pulmonary Disease (COPD) is prevalent, with an estimated 75% of adults suffering from COPD in the US, without clinical recognition. Often, the first diagnosis of COPD comes with a flare or exacerbation. In one study, 34% of patients were first diagnosed during hospitalization for an exacerbation, an event associated with a 1-year mortality rate of 26%. When COPD is finally diagnosed, it is often in the late stages, with an average lung function of 50% of normal. Conversely, COPD can be over-diagnosed, defined as symptoms in an individual without airflow obstruction. Over-diagnosed people have significantly higher rates of hospitalization, ER visits, and ambulatory care visits because individuals are treated for a disorder they don't have and are not being treated for the disorder they do have. Lack of diagnostic clarity places patients at risk of medication complications without potential benefit. Conversely, failure to diagnose preempts the benefits of therapy. To date, no reliable solution has been found to address this problem.


Eligibility

Min Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study is validating a computerized algorithm that uses electronic health record data to identify patients who have — or are at risk of developing — chronic obstructive pulmonary disease (COPD), a progressive lung condition that causes breathing difficulties. The goal is to help catch COPD earlier and more reliably. **You may be eligible if...** - You are 40 years of age or older - You have had at least 2 healthcare visits recorded in the health system - You have had a lung function test (pulmonary function test, or PFT) recorded in your medical records within the past 5 years **You may NOT be eligible if...** - You have cystic fibrosis or Alpha-1 Antitrypsin Deficiency - You are currently pregnant - You have had a lung transplant or had part of a lung surgically removed - You have a significant chest wall deformity - You have a neuromuscular disease affecting your breathing muscles - You have had surgery requiring general anesthesia or an overnight hospital stay within the past 30 days Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

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NCT07223749


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