COPD ExacerbationNCT06379529
The COPD CARE Study: Evaluating the Impact of a Virtual-First COPD Service on Major Cardiac and Respiratory Events
A study testing NuvoAir clinical service in people with COPD Exacerbation and COPD, run by NuvoAir Medical PC.
Trial summary
A 12 month interventional study of up to 1,050 people with COPD to determine if the NuvoAir virtual-first clinical service leads to fewer moderate and severe COPD exacerbations and cardiac events, reduces healthcare utilization, and lowers the total cost of care compared to a control cohort that receives standard care… Read more about this study
- Who is it for?
- Ages 30 to 100 years
- Conditions the study is for
- COPD Exacerbation, COPD, Cardio/Pulm: Heart Failure
- What is being tested?
- NuvoAir clinical service
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,050 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 1 Dec 2027
- Phase
- Interventional
- 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 30 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Twelve months of claims data in the health insurer or provider's database for baseline
- ICD10 code for COPD (including emphysema and chronic bronchitis) with a severe exacerbation of COPD in the previous 12 months (defined as ER visit or hospitalization related to COPD or severity score of 2 or 3)
- Cooperative, i.e., subject should be able to follow and understand instructions
- Access to a phone (smartphone, cell phone, or landline)
- Willingness to sign a medical release form for treating healthcare facilities
Who cannot join
- Does not have access to a a phone (smartphone, cell phone, or landline)
- Lack of cooperation, subject cannot follow and understand instructions
- Other serious medical illness that, in the opinion of the PI, would interfere with the patient's participation in the study or interpretation of their data (i.e., terminal illness, unstable psychiatric condition, etc.)
- Does not understand English
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
A 12 month interventional study of up to 1,050 people with COPD to determine if the NuvoAir virtual-first clinical service leads to fewer moderate and severe COPD exacerbations and cardiac events, reduces healthcare utilization, and lowers the total cost of care compared to a control cohort that receives standard care only.
Read the detailed description
A virtual (decentralized), pragmatic, prospective, matched cohort study conducted in patients with COPD residing in the United States of America who are enrolled with one or more health insurers or providers supporting the study. The study aims to evaluate COPD outcomes with the addition of the NuvoAir virtual-first clinical service compared to a cohort receiving standard care (matched control - no intervention).
Each patient in the NuvoAir cohort will receive routine clinical care from their providers with the addition of the NuvoAir clinical service. The NuvoAir clinical service offers comprehensive monitoring of health parameters and patient-reported outcomes as well as personalized clinical and behavioral interventions tailored to the patients' unique needs and clinical risk. The service involves virtual interaction with NuvoAir coaches who provide guidance and assistance in navigating and utilizing the service. Dedicated NuvoAir care coordinators are available to offer self-management support and educational resources, aiming to enhance the management of COPD and comorbidities such as cardiovascular conditions. In situations where patients encounter new or worsening symptoms, the NuvoAir clinical team is accessible to provide advice and triage, as required.
Each patient in the standard care cohort will receive their routine clinical care from their healthcare provider. Only de-identified data that is usually collected by their health insurer or provider will be subject to analysis, no additional data will be collected for the standard care cohort.
NuvoAir and standard care cohorts will be matched on the basis of age, gender, disease severity (ICD10 code for COPD with a severe exacerbation of COPD in the previous 12 months or disease severity score of 2 or 3 as defined by their health plan) and period of entry into the study. Eligible patients will be recruited from Medicare patients in Medicare Advantage plans that are administered by the private health insurance company or health care provider supporting the study.
Key Objectives: To determine if use of the NuvoAir clinical service results in a reduction in the rate and number of moderate and severe exacerbations of COPD; major cardiac events; hospitalizations and 30-day readmissions; days hospitalized; and lowers healthcare costs compared with the matched cohort of patients receiving standard care only.
Study duration: The overall study duration is expected to be two years with one year of active patient participation using the NuvoAir clinical service following the end of the baseline period. This will be followed by one year of follow-up by reference to health insurer or provider's records.
Enrollment: The study will enroll up to 350 patients for the NuvoAir intervention and 700 for the standard care cohort for a total of 1,050 patients.
- Conditions
- COPD Exacerbation, COPD, Cardio/Pulm: Heart Failure
- Being tested
- NuvoAir clinical service
- Keywords
- COPD, COPD Exacerbation, COPD Hospitalization, COPD Readmission, COPD Costs, Medicare, Medicare Advantage
- 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.
NuvoAir clinical serviceOther
Patients with COPD receiving usual care plus NuvoAir clinical services.
| Study group | Role | What they receive |
|---|---|---|
| NuvoAir clinical service | Experimental | Patients with COPD receiving usual care plus the NuvoAir clinical service.The NuvoAir clinical service offers comprehensive remote monitoring of health parameters and patient-reported outcomes as well as personalized clinical and behavioral interventions tailored to the patients' unique needs and clinical risk. The service involves virtual interaction with NuvoAir coaches who provide guidance and assistance in navigating and utilizing the service; dedicated NuvoAir care coordinators for self-management support and educational resources, aiming to enhance the management of COPD and other comorbidities including cardiovascular conditions. In situations where patients encounter new or worsening symptoms, the NuvoAir clinical team is accessible to advise and triage as required. Receives: Other: NuvoAir clinical service |
| Standard Care | No intervention | Propensity matched controls with COPD who receive usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Moderate & Severe Exacerbations
Rate of moderate and severe exacerbations of COPD, measured by the health insurer or provider's records
Measured: 12 months
Secondary outcomes (9)
Severe COPD Exacerbations
Proportion of patients with at least one episode of severe COPD exacerbation within a 12-month period, NuvoAir cohort vs standard care cohort
Measured: 12 months
Major Adverse Cardiac Event
Proportion of patients using the NuvoAir clinical service who have experienced a major adverse cardiac event (including CHF exacerbations, ACS/AMI, stroke) or all cause death, compared with the standard care cohort, measured using health insurer or provider records and assessed each year of the study
Measured: 12 months
30-Day COPD Related Readmissions
Number of readmissions due to COPD exacerbation within a 30 day period following a COPD exacerbation (NuvoAir cohort only), compared to baseline and the number of 30-day readmissions after hospitalisation due to a COPD exacerbation compared to the standard care cohort
Measured: 12 months
All-Cause Hospitalizations
Proportion of patients using the NuvoAir clinical service who have experienced an all-cause admission to hospital, compared with the standard care cohort, measured using health insurer or provider records and assessed each year of the study
Measured: 12 months
All-Cause Readmissions
Number of all cause readmissions within a 30 day period following a COPD exacerbation, compared with the standard care cohort
Measured: 12 months
Days Hospitalized due to COPD
Total number of days hospitalized due to COPD exacerbation, compared to the standard care cohort
Measured: 12 months
Cost of Care Related to COPD
Cost of care related to COPD, including hospitalization, emergency room visits, urgent care visits, hospital visits, outpatient visits, and pharmacy costs, for those using NuvoAir Home compared with the standard care cohort
Measured: 12 months
Medication Adherence
Percentage of the total doses of medication taken, which is the number of doses taken within a given time divided by the number of doses prescribed by a physician during the same time in NuvoAir cohort only
Measured: 12 months
Quality of Life (QOL)
Quality of life measured using the SGRQ-C collected at baseline and at the end of the study
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2024
- Study start1 Jan 2026 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD ExacerbationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Pragmatic evaluation of a clinical service using a prospective cohort comparison of intervention vs propensity matched controls.
- Masking
- None (open label)
- Enrolment
- 1,050 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NuvoAir Medical PC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Optum, Inc.
- Responsible party
- Sponsor
- Investigators
- Ken Cohen, MD, Principal investigator, Executive Director of Translational Research, OptumCare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06379529
- Sponsor's protocol ID
- USCOPD2022B
- Status last verified
- May 2025
- First submitted
- 25 Aug 2023
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The COPD CARE Study: Evaluating the Impact of a Virtual-First COPD Service on Major Cardiac and Respiratory Events
- ClinicalTrials.gov ID
- NCT06379529
- Acronym / sponsor ID
- USCOPD2022B
- Conditions
- COPD Exacerbation, COPD, Cardio/Pulm: Heart Failure
- Keywords
- COPD, COPD Exacerbation, COPD Hospitalization, COPD Readmission, COPD Costs, Medicare, Medicare Advantage
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,050 participants (estimated)
- Lead sponsor
- NuvoAir Medical PCIndustry (pharma, biotech, devices)
- Collaborators
- Optum, Inc.
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 23 Apr 2024 (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.
A 12 month interventional study of up to 1,050 people with COPD to determine if the NuvoAir virtual-first clinical service leads to fewer moderate and severe COPD exacerbations and cardiac events, reduces healthcare utilization, and lowers the total cost of care compared to a control cohort that receives standard care only.
Detailed description
A virtual (decentralized), pragmatic, prospective, matched cohort study conducted in patients with COPD residing in the United States of America who are enrolled with one or more health insurers or providers supporting the study. The study aims to evaluate COPD outcomes with the addition of the NuvoAir virtual-first clinical service compared to a cohort receiving standard care (matched control - no intervention).
Each patient in the NuvoAir cohort will receive routine clinical care from their providers with the addition of the NuvoAir clinical service. The NuvoAir clinical service offers comprehensive monitoring of health parameters and patient-reported outcomes as well as personalized clinical and behavioral interventions tailored to the patients' unique needs and clinical risk. The service involves virtual interaction with NuvoAir coaches who provide guidance and assistance in navigating and utilizing the service. Dedicated NuvoAir care coordinators are available to offer self-management support and educational resources, aiming to enhance the management of COPD and comorbidities such as cardiovascular conditions. In situations where patients encounter new or worsening symptoms, the NuvoAir clinical team is accessible to provide advice and triage, as required.
Each patient in the standard care cohort will receive their routine clinical care from their healthcare provider. Only de-identified data that is usually collected by their health insurer or provider will be subject to analysis, no additional data will be collected for the standard care cohort.
NuvoAir and standard care cohorts will be matched on the basis of age, gender, disease severity (ICD10 code for COPD with a severe exacerbation of COPD in the previous 12 months or disease severity score of 2 or 3 as defined by their health plan) and period of entry into the study. Eligible patients will be recruited from Medicare patients in Medicare Advantage plans that are administered by the private health insurance company or health care provider supporting the study.
Key Objectives: To determine if use of the NuvoAir clinical service results in a reduction in the rate and number of moderate and severe exacerbations of COPD; major cardiac events; hospitalizations and 30-day readmissions; days hospitalized; and lowers healthcare costs compared with the matched cohort of patients receiving standard care only.
Study duration: The overall study duration is expected to be two years with one year of active patient participation using the NuvoAir clinical service following the end of the baseline period. This will be followed by one year of follow-up by reference to health insurer or provider's records.
Enrollment: The study will enroll up to 350 patients for the NuvoAir intervention and 700 for the standard care cohort for a total of 1,050 patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pragmatic evaluation of a clinical service using a prospective cohort comparison of intervention vs propensity matched controls.
| Arm | Type | Receives |
|---|---|---|
| NuvoAir clinical service | Experimental | Other: NuvoAir clinical servicePatients with COPD receiving usual care plus the NuvoAir clinical service.The NuvoAir clinical service offers comprehensive remote monitoring of health parameters and patient-reported outcomes as well as personalized clinical and behavioral interventions tailored to the patients' unique needs and clinical risk. The service involves virtual interaction with NuvoAir coaches who provide guidance and assistance in navigating and utilizing the service; dedicated NuvoAir care coordinators for self-management support and educational resources, aiming to enhance the management of COPD and other comorbidities including cardiovascular conditions. In situations where patients encounter new or worsening symptoms, the NuvoAir clinical team is accessible to advise and triage as required. |
| Standard Care | No intervention | –Propensity matched controls with COPD who receive usual care. |
Who may qualify
- Ages
- 30 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Twelve months of claims data in the health insurer or provider's database for baseline
- ICD10 code for COPD (including emphysema and chronic bronchitis) with a severe exacerbation of COPD in the previous 12 months (defined as ER visit or hospitalization related to COPD or severity score of 2 or 3)
- Cooperative, i.e., subject should be able to follow and understand instructions
- Access to a phone (smartphone, cell phone, or landline)
- Willingness to sign a medical release form for treating healthcare facilities
Key exclusion criteria (4 listed)
- Does not have access to a a phone (smartphone, cell phone, or landline)
- Lack of cooperation, subject cannot follow and understand instructions
- Other serious medical illness that, in the opinion of the PI, would interfere with the patient's participation in the study or interpretation of their data (i.e., terminal illness, unstable psychiatric condition, etc.)
- Does not understand English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NuvoAir clinical servicePatients with COPD receiving usual care plus NuvoAir clinical services. | Other | NuvoAir clinical service |
Primary outcome
Moderate & Severe Exacerbations
Time frame: 12 months
Rate of moderate and severe exacerbations of COPD, measured by the health insurer or provider's records
9 secondary outcomes
Severe COPD Exacerbations
Time frame: 12 months
Major Adverse Cardiac Event
Time frame: 12 months
30-Day COPD Related Readmissions
Time frame: 12 months
All-Cause Hospitalizations
Time frame: 12 months
All-Cause Readmissions
Time frame: 12 months
Days Hospitalized due to COPD
Time frame: 12 months
Cost of Care Related to COPD
Time frame: 12 months
Medication Adherence
Time frame: 12 months
Quality of Life (QOL)
Time frame: 12 months
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 28 May 2025.
- Individual participant dataSharing planned: No
Related trials for COPD Exacerbation
RecruitingObservational study
Characteristics and Outcomes of Patients Admitted to ICU for a Severe Acute Exacerbation of COPD.
COPD Exacerbation, ICU
RecruitingPhase 2
Rademikibart IV for Acute Asthma and COPD Exacerbation
Asthma Acute, COPD Exacerbation Acute
Active, not recruitingObservational study
CareCOPD - COPD Home Monitoring Study
Chronic Obstructive Pulmonary Disease
Recruiting
A Prospective Study of Cardiovascular Risk of Patients Admitted for Acute Exacerbation of COPD
COPD
Not yet recruitingPhase 4
Efficacy of Nebulized Long-Acting Bronchodilators (Formoterol and Revefenacin) vs. Short-Acting Bronchodilators (Albuterol and Ipratropium) in Patients Presenting to the Emergency Department With Acute Exacerbation of COPD (ECOPD)
COPD Exacerbation
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.
Ken Cohen, MD principal investigator
Executive Director of Translational Research, OptumCare
Questions about this trial
What is this clinical trial studying?
A study testing NuvoAir clinical service in people with COPD Exacerbation and COPD, run by NuvoAir Medical PC.
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 4 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: opening soon, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Eric Harker, MD ((303)748-5781, eric.harker@nuvoair.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Moderate & Severe Exacerbations (time frame: 12 months). 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 May 2025.