COPD (Chronic Obstructive Pulmonary Disease)NCT07118306
COPD Exacerbation Follow Up
An observational study of COPD (Chronic Obstructive Pulmonary Disease), run by Viz.ai, Inc. at 5 sites in United States.
Trial summary
The goal of this study is to evaluate the impact of implementing an AI-enabled clinical workflow tool (Viz COPD) on respiratory specialist follow up and clinical outcomes after an acute 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
- 485 participants
- Where
- 5 sitesUnited States
- Study dates
- 27 Feb 2026to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Target of five geographically dispersed U.S. hospital systems to capture a diverse patient population and COPD clinical workflow.
Who may be able to join
- Patients aged 40 years or older at the time of arrival to the emergency department.
- Patients with a clinical diagnosis of COPD who present to the emergency department for a moderate or severe COPD exacerbation.
- A moderate exacerbation is defined as an acute exacerbation requiring either systemic corticosteroids (such as intramuscular, intravenous or oral) and/or antibiotics.
- A severe exacerbation is defined as an acute exacerbation requiring hospitalization, or observation for >24 hours in emergency department/urgent care facility or resulting in death.
- Patients on dual (LABA/LAMA, LABA/ICS, LAMA/ICS) or triple (LABA/LAMA/ICS) long-acting bronchodilator inhalers.
Who cannot join
- Patients on bronchodilator inhaler monotherapy.
- Patients leaving against medical advice or expiring during hospitalization.
- Patients with tracheostomy.
- Patients with advanced cancer.
- Patients who have received a lung transplant.
- Discharge to hospice care.
- Transfer to another hospital.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Cooper University Health Care
Cherry Hill, New Jersey, 08002
Study Coordinator, 856-342-2000 ext. 1007303, Falcon-Tashi@cooperhealth.edu
Ramya Lotano, MD
- Not yet recruiting
Inova Fairfax Hospital
Falls Church, Virginia, 22042
Edwinia Battle, 703-776-3067, edwinia.battle@inova.org
Rabih Halabi, MD
- Not yet recruiting
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
Manager Clinical Trials Research, Multispecialty, 920-360-9415, alexander.albers@aah.org
Theodore Gronski, MD
- Recruiting
Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068
Manager Clinical Trials Research, Multispecialty, 920-360-9415, alexander.albers@aah.org
Bhaven Shah, MD
- Recruiting
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Research Coordinator, 215-955-9181, pritika.manna@jefferson.edu
Ross Summer, MD
About this study
Official title: A Multicenter Study of the Impact of a COPD Identification and Referral System on Patient Follow Up and Outcomes After an Acute COPD Exacerbation Resulting in an Emergency Department Visit or Hospitalization
The goal of this study is to evaluate the impact of implementing an AI-enabled clinical workflow tool (Viz COPD) on respiratory specialist follow up and clinical outcomes after an acute exacerbation.
Read the detailed description
Time perspective: This study will collect data prospectively for the Experimental cohort and retrospectively for the Control cohort. There is also an Exploratory cohort which will collect retrospective and prospective data.
- Keywords
- COPD, Chronic obstructive pulmonary disease, Exacerbation, VizCOPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Cohort | Prospective patients presenting to sites after implementation of the digital health tool. | |
| Control Cohort | Retrospective patients who presented to the same study sites under the standard of care clinical workflow before implementation of the digital health tool | |
| Exploratory Cohort | Patients who had no prior respiratory specialist follow up before implementation of the digital health tool and are re-assessed for follow up after implementation of the digital health tool. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the effect of a digital health tool implementation on patient follow up with a respiratory specialist within 30 days after discharge for an acute COPD exacerbation resulting in an emergency department visit or hospitalization.
Proportion of patients with a respiratory specialist follow-up visit within 30 days after discharge in the experimental cohort compared to the control cohort.
Measured: From time of exacerbation to 30 days after discharge
To assess the effect of a digital health tool implementation on time to respiratory specialist follow-up after an acute COPD exacerbation resulting in an emergency department visit or hospitalization.
Time from discharge to respiratory specialist follow-up visit in the experimental cohort compared to the control cohort.
Measured: Up to 1 year
Secondary outcomes (15)
To assess the effect of a digital health tool implementation on patient follow up with a respiratory specialist within 90 days after discharge for an acute COPD exacerbation resulting in an emergency department visit or hospitalization.
Proportion of patients with a respiratory specialist follow-up visit within 90 days after discharge in the experimental cohort compared to the control cohort.
Measured: Enrollment to 90 days after discharge
To assess the effect of a digital health tool implementation on readmission following an acute, severe COPD exacerbation.
Proportion of patients with all-cause readmission within 30 days after discharge in the experimental cohort compared to the control cohort.
Measured: Enrollment to 30 days after discharge
To assess the effect of a digital health tool implementation on readmission following an acute, severe COPD exacerbation.
Proportion of patients with all-cause readmission within 90 days after discharge in the experimental cohort compared to the control cohort.
Measured: Enrollment to 90 days after discharge
To compare exacerbation rate (moderate, moderate and severe, severe) in the experimental and control cohort after an acute COPD exacerbation resulting in an emergency department visit or hospitalization.
Proportion of patients with an acute exacerbation (moderate, moderate and severe, severe) within 30 days after discharge in the experimental cohort compared to the control cohort
Measured: Enrollment to 30 days after discharge
To compare exacerbation rate (moderate, moderate and severe, severe) in the experimental and control cohort after an acute COPD exacerbation resulting in an emergency department visit or hospitalization.
Proportion of patients with an acute exacerbation (moderate, moderate and severe, severe) within 90 days after discharge in the experimental cohort compared to the control cohort
Measured: Enrollment to 90 days post discharge
To compare exacerbation rate (moderate, moderate and severe, severe) in the experimental and control cohort after an acute COPD exacerbation resulting in an emergency department visit or hospitalization.
Rate of acute exacerbations (moderate, moderate and severe, severe) at 1 year after discharge in the experimental cohort compared to the control cohort.
Measured: Enrollment to 1 year post discharge
To compare healthcare resource utilization in the experimental and control cohort following discharge for an acute COPD exacerbation resulting in an emergency department visit or hospitalization.
Proportion of patients with a composite outcome consisting of emergency department visits, readmissions, or exacerbations within 30 days after discharge in the experimental cohort compared to the control cohort
Measured: Enrollment through 30 days after discharge
To compare healthcare resource utilization in the experimental and control cohort following discharge for an acute COPD exacerbation resulting in an emergency department visit or hospitalization.
Proportion of patients with a composite outcome consisting of emergency department visits, readmissions, or exacerbations within 90 days after discharge inthe experimental cohort compared to the control cohort.
Measured: Enrollment through 90 days after discharge
To compare healthcare resource utilization in the experimental and control cohort following discharge for an acute COPD exacerbation resulting in an emergency department visit or hospitalization - 1 year
Rate of a composite outcome consisting of emergency department visits, readmissions, or exacerbations at 1 year after discharge in the experimental cohort compared to the control cohort.
Measured: Enrollment through 1 year after discharge
To compare the rate of cardiovascular events in the experimental and control cohort after an acute COPD exacerbation resulting in an emergency department visit or hospitalization - 30 days
Proportion of patients with a cardiovascular event within 30 days after discharge in the experimental cohort compared to the control cohort.
Measured: Enrollment through 30 days after discharge
To compare the rate of cardiovascular events in the experimental and control cohort after an acute COPD exacerbation resulting in an emergency department visit or hospitalization - 1 year
Rate of cardiovascular events at 1 year after discharge in the experimental cohort compared to the control cohort.
Measured: Enrollment through 1 year after discharge
To compare patient mortality in the experimental and control cohort after an acute COPD exacerbation resulting in an emergency department visit or hospitalization - 30 days
Proportion of patients with allcause mortality within 30 days after discharge in the experimental cohort compared to the control cohort
Measured: Enrollment through 30 days after discharge
To compare patient mortality in the experimental and control cohort after an acute COPD exacerbation resulting in an emergency department visit or hospitalization.
Proportion of patients with allcause mortality within 90 days after discharge in the experimental cohort compared to the control cohort.
Measured: Enrollment through 90 days after discharge
To compare patient mortality in the experimental and control cohort after an acute COPD exacerbation resulting in an emergency department visit or hospitalization - 1 year.
Rate of all-cause mortality at 1 year after discharge in the experimental cohort compared to the control cohort.
Measured: Enrollment through 1 year after discharge
To assess the impact of a digital health tool implementation on achieving pharmacological treatment that is consistent with the GOLD treatment recommendations after an acute COPD exacerbation resulting in an emergency department visit or hospitalization.
The proportion of patients in the experimental cohort with pharmacological treatment consistent with the GOLD treatment recommendations at 30 and 90 days after discharge for the index exacerbation compared to the control cohort.
Measured: Enrollment through 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start27 Feb 2026
- Primary completionJul 2027 (estimated)
- Study completionDec 2027 (estimated)
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-control
- Time perspective
- Other
- Enrolment
- 485 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Viz.ai, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sanofi, Regeneron Pharmaceuticals
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07118306
- Sponsor's protocol ID
- VIZCOPD03
- Status last verified
- Aug 2026
- First submitted
- 1 Aug 2025
- Last updated
- 2 Sep 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 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Study of the Impact of a COPD Identification and Referral System on Patient Follow Up and Outcomes After an Acute COPD Exacerbation Resulting in an Emergency Department Visit or Hospitalization
- ClinicalTrials.gov ID
- NCT07118306
- Acronym / sponsor ID
- VIZCOPD03
- Keywords
- COPD, Chronic obstructive pulmonary disease, Exacerbation, VizCOPD
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 485 participants (estimated)
- Lead sponsor
- Viz.ai, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Sanofi, Regeneron Pharmaceuticals
- Study start
- 27 Feb 2026 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 12 Aug 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.
The goal of this study is to evaluate the impact of implementing an AI-enabled clinical workflow tool (Viz COPD) on respiratory specialist follow up and clinical outcomes after an acute exacerbation.
Detailed description
Time perspective: This study will collect data prospectively for the Experimental cohort and retrospectively for the Control cohort. There is also an Exploratory cohort which will collect retrospective and prospective data.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental Cohort | – | –Prospective patients presenting to sites after implementation of the digital health tool. |
| Control Cohort | – | –Retrospective patients who presented to the same study sites under the standard of care clinical workflow before implementation of the digital health tool |
| Exploratory Cohort | – | –Patients who had no prior respiratory specialist follow up before implementation of the digital health tool and are re-assessed for follow up after implementation of the digital health tool. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Target of five geographically dispersed U.S. hospital systems to capture a diverse patient population and COPD clinical workflow.
Key inclusion criteria (5 listed)
- Patients aged 40 years or older at the time of arrival to the emergency department.
- Patients with a clinical diagnosis of COPD who present to the emergency department for a moderate or severe COPD exacerbation.
- A moderate exacerbation is defined as an acute exacerbation requiring either systemic corticosteroids (such as intramuscular, intravenous or oral) and/or antibiotics.
- A severe exacerbation is defined as an acute exacerbation requiring hospitalization, or observation for >24 hours in emergency department/urgent care facility or resulting in death.
- Patients on dual (LABA/LAMA, LABA/ICS, LAMA/ICS) or triple (LABA/LAMA/ICS) long-acting bronchodilator inhalers.
Key exclusion criteria (7 listed)
- Patients on bronchodilator inhaler monotherapy.
- Patients leaving against medical advice or expiring during hospitalization.
- Patients with tracheostomy.
- Patients with advanced cancer.
- Patients who have received a lung transplant.
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
To assess the effect of a digital health tool implementation on patient follow up with a respiratory specialist within 30 days after discharge for an acute COPD exacerbation resulting in an emergency department visit or hospitalization.
Time frame: From time of exacerbation to 30 days after discharge
Proportion of patients with a respiratory specialist follow-up visit within 30 days after discharge in the experimental cohort compared to the control cohort.
To assess the effect of a digital health tool implementation on time to respiratory specialist follow-up after an acute COPD exacerbation resulting in an emergency department visit or hospitalization.
Time frame: Up to 1 year
Time from discharge to respiratory specialist follow-up visit in the experimental cohort compared to the control cohort.
15 secondary outcomes
To assess the effect of a digital health tool implementation on patient follow up with a respiratory specialist within 90 days after discharge for an acute COPD exacerbation resulting in an emergency department visit or hospitalization.
Time frame: Enrollment to 90 days after discharge
To assess the effect of a digital health tool implementation on readmission following an acute, severe COPD exacerbation.
Time frame: Enrollment to 30 days after discharge
To assess the effect of a digital health tool implementation on readmission following an acute, severe COPD exacerbation.
Time frame: Enrollment to 90 days after discharge
To compare exacerbation rate (moderate, moderate and severe, severe) in the experimental and control cohort after an acute COPD exacerbation resulting in an emergency department visit or hospitalization.
Time frame: Enrollment to 30 days after discharge
To compare exacerbation rate (moderate, moderate and severe, severe) in the experimental and control cohort after an acute COPD exacerbation resulting in an emergency department visit or hospitalization.
Time frame: Enrollment to 90 days post discharge
To compare exacerbation rate (moderate, moderate and severe, severe) in the experimental and control cohort after an acute COPD exacerbation resulting in an emergency department visit or hospitalization.
Time frame: Enrollment to 1 year post discharge
To compare healthcare resource utilization in the experimental and control cohort following discharge for an acute COPD exacerbation resulting in an emergency department visit or hospitalization.
Time frame: Enrollment through 30 days after discharge
To compare healthcare resource utilization in the experimental and control cohort following discharge for an acute COPD exacerbation resulting in an emergency department visit or hospitalization.
Time frame: Enrollment through 90 days after discharge
To compare healthcare resource utilization in the experimental and control cohort following discharge for an acute COPD exacerbation resulting in an emergency department visit or hospitalization - 1 year
Time frame: Enrollment through 1 year after discharge
To compare the rate of cardiovascular events in the experimental and control cohort after an acute COPD exacerbation resulting in an emergency department visit or hospitalization - 30 days
Time frame: Enrollment through 30 days after discharge
To compare the rate of cardiovascular events in the experimental and control cohort after an acute COPD exacerbation resulting in an emergency department visit or hospitalization - 1 year
Time frame: Enrollment through 1 year after discharge
To compare patient mortality in the experimental and control cohort after an acute COPD exacerbation resulting in an emergency department visit or hospitalization - 30 days
Time frame: Enrollment through 30 days after discharge
To compare patient mortality in the experimental and control cohort after an acute COPD exacerbation resulting in an emergency department visit or hospitalization.
Time frame: Enrollment through 90 days after discharge
To compare patient mortality in the experimental and control cohort after an acute COPD exacerbation resulting in an emergency department visit or hospitalization - 1 year.
Time frame: Enrollment through 1 year after discharge
To assess the impact of a digital health tool implementation on achieving pharmacological treatment that is consistent with the GOLD treatment recommendations after an acute COPD exacerbation resulting in an emergency department visit or hospitalization.
Time frame: Enrollment through 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 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.
Cooper University Health Care
Cherry Hill, United States
5 sites 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 Viz.ai, Inc. at 5 sites 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 5 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the effect of a digital health tool implementation on patient follow up with a respiratory specialist within 30 days after discharge for an acute COPD exacerbation resulting in an emergency department visit or hospitalization. (time frame: From time of exacerbation to 30 days after discharge). The study lists 2 primary outcomes in all. 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 2 Sep 2026.