Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07223749

Validation of Chronic Obstructive Pulmonary Disease (COPD) Algorithm

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location status: Recruiting

Location contact

Brian J Wells, MD, PhD

PRINCIPAL_INVESTIGATOR

Brian Wells, PhD, MD

CONTACT

[email protected]

336-257-7128

Lynnette Harris, BSN

CONTACT

[email protected]

336-716-8791

About this study

Guideline based therapy for COPD includes bronchodilators in conjunction with smoking cessation, vaccination and pulmonary rehabilitation. Bronchodilators have repeatedly been shown to improve symptoms, lung function and quality of life and to reduce exacerbations and possibly mortality in individuals with documented COPD. Despite these findings, the US Preventive Services Task Force recommends against screening for COPD because its value has not been demonstrated in "asymptomatic" individuals. Symptoms such as cough, dyspnea, and wheezing are nonspecific and are common in other disorders such as asthma, kidney failure, and heart disease. Furthermore, COPD is an indolent disease, allowing accommodation to the slowly progressive symptoms. To address this significant under-diagnosis problem, the Global Obstructive Lung Disease (GOLD) Committee recommends "targeted case finding" for patients at risk. Smoking is a risk factor for COPD; however, a quarter of COPD patients are never smokers. The GOLD Guidelines suggest two assessment tools, these tools are designed to detect early symptomatic disease with physician administered patient questionnaires, limiting their use for automated, widespread screening.

Risk stratification tools relying entirely on existing, structured Electronic Health Record (EHR) data would provide an opportunity for screening interventions. The most efficient EHR tool would not include symptoms as a predictor variable since the documentation of symptoms are inconsistent and are typically recorded in unstructured text. Automated screening facilitates targeted screening of high-risk patients, including those individuals with limited contact with the health system. This study has created an accurate tool for this purpose that was cross-validated on a potentially biased set of patients who already underwent spirometric testing.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

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

    Time frame: minute 10

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Brian J Wells, MD

CONTACT

[email protected]

336-257-7128

Lynnette Harris, BSN

CONTACT

[email protected]

336-716-8791

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

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

Acronym: COPD

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 3, 2025
Registry last updated
Nov 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.