COPD (Chronic Obstructive Pulmonary Disease)COPDNCT07223749
Validation of Chronic Obstructive Pulmonary Disease (COPD) Algorithm
An observational study of COPD (Chronic Obstructive Pulmonary Disease), run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD (Chronic Obstructive Pulmonary Disease)
- How many people
- 425 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Aug 2025to 15 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: Validation of a Chronic Obstructive Pulmonary Disease (COPD) Predictive 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.
Read the detailed description
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.
- Keywords
- pulmonary function test, COPD, airflow obstruction
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: minute 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2025
- Study start22 Aug 2025
- Primary completion15 May 2026
- Study completion15 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD (Chronic Obstructive Pulmonary Disease)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 425 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brian J Wells, MD, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07223749
- Sponsor's protocol ID
- IRB00121215
- Acronym
- COPD
- Status last verified
- Oct 2025
- First submitted
- 31 Oct 2025
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Chronic Obstructive Pulmonary Disease (COPD) Predictive Algorithm
- ClinicalTrials.gov ID
- NCT07223749
- Acronym / sponsor ID
- COPD / IRB00121215
- Keywords
- pulmonary function test, COPD, airflow obstruction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 425 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 22 Aug 2025 (actual)
- Primary completion
- 15 May 2026 (actual)
- Study completion
- 15 May 2026 (actual)
- First posted
- 3 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian J Wells, MD, PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD (Chronic Obstructive Pulmonary Disease), run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
obtainment of the accuracy of a model for predicting the presence of obstruction on spirometry (time frame: minute 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026; AzTrials last refreshed its copy on 28 Oct 2026.