Validation of Chronic Obstructive Pulmonary Disease (COPD) Algorithm

NCT07223749 | Recruiting

• 1 other identifier: IRB00121215
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

pulmonary function test; COPD; airflow obstruction

Outcome Measures

Primary Outcomes (1)

• obtainment of the accuracy of a model for predicting the presence of obstruction on spirometry

  prospectively evaluate our tool on a population of patients regardless of underlying COPD risk - It will be an analysis using the algorithm developed by Dr. Wells of the percentage of subjects who demonstrated obstructive airway disease

  minute 10

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Data from the Wake Forest Baptist Medical Center in Winston Salem, NC and Lexington Medical Center in Lexington, NC were extracted from a common electronic health record system. Algorithm development included 15,065 patients who underwent pulmonary function testing in 2016-2022.

You may qualify if:

• greater thank or equal to 40 years of age
• or more encounters in the health system
• Previous Pulmonary Function Test (PFT) recorded in our Electronic Health Records (EHR) in the previous 5 years

You may not qualify if:

• cystic fibrosis
• Alpha-1 Antitrypsin Deficiency (AAD)currently pregnant
• History of a lung transplant or partial removal of the lung
• significant chest wall deformity
• neuromuscular disease that currently impacts the respiratory muscles
• surgery requiring general anesthesia or an overnight stay in the hospital within the past 30 days

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Brian J Wells, MD, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brian J Wells, MD

CONTACT

336-257-7128; Brian.Wells@Advocatehealth.org

Lynnette Harris, BSN

CONTACT

336-716-8791; lynnette.harris@advocatehealth.org

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2025
• First Posted: November 3, 2025
• Study Start: August 22, 2025
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: November 3, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)