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Validation of Chronic Obstructive Pulmonary Disease (COPD) Algorithm

NCT07223749 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2025-11-03

No results posted yet for this study

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.

Conditions

  • COPD (Chronic Obstructive Pulmonary Disease)

Sponsors & Collaborators

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Brian J Wells, MD, PhD · Wake Forest University Health Sciences

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-22
Primary Completion
2026-08-30
Completion
2026-12-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07223749 on ClinicalTrials.gov