Validation of Chronic Obstructive Pulmonary Disease (COPD) Algorithm

Part of paid clinical trials in Winston-Salem, North Carolina.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT07223749
Status
Recruiting
Apply to this trial

Conditions

  • COPD (Chronic Obstructive Pulmonary Disease)

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Aug 22, 2025
Status verified
Oct 2025
Primary completion
Aug 30, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
500 participants (estimated)

Primary Outcome Measure

obtainment of the accuracy of a model for predicting the presence of obstruction on spirometry [ Time Frame: minute 10 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Wake Forest University Health SciencesWinston-SalemNorth Carolina27157
Brian Wells, PhD, MD
[email protected]
336-257-7128
Lynnette Harris, BSN
[email protected]
336-716-8791
Brian J Wells, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Winston-Salem, NC

By research site
Wake Forest University Health Sciences· Winston-Salem, NC

Related Studies