Clinical Trial

Validation of Chronic Obstructive Pulmonary Disease (COPD) Algorithm

Study acronym: COPD
Recruiting
View on ClinicalTrials.gov →
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.
Trial Details
NCT Number NCT07223749
Lead Sponsor Wake Forest University Health Sciences
Conditions COPD (Chronic Obstructive Pulmonary Disease)
Enrollment 500 participants
Start Date 2025-08-22
Primary Completion 2026-08-30 (estimated)
Study Completion 2026-12-30 (estimated)
Updated on ClinicalTrials.gov 2025-11-03