NuvoAir Clinical Service for COPD

(PROMISE Trial)

Overseen By Eric Harker, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NuvoAir Medical PC

Disqualifiers: Terminal illness, Substance abuse, Unstable mental illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether the NuvoAir clinical service can help people with COPD (a lung disease that makes breathing difficult) experience fewer severe flare-ups and reduce hospital visits and healthcare costs. Participants will either receive the NuvoAir service along with their usual care or continue with their usual care alone. The trial seeks individuals diagnosed with COPD, including emphysema or chronic bronchitis, within the last two years who have access to a phone.

As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the NuvoAir Clinical Service is safe for COPD patients?

Research has shown that the NuvoAir Clinical Service is generally easy for patients to use. Early results suggest it helps reduce hospital visits without causing new issues. Specifically, 80% of patients reported fewer hospital visits related to COPD after using the service. This indicates the service is both effective and safe for people with COPD. Studies have found no major negative effects. While more research is always useful, the current findings are promising for safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The NuvoAir Clinical Service is unique because it integrates innovative technology with standard COPD care. Unlike traditional treatments that primarily focus on medications and physical therapies, NuvoAir enhances patient management by providing remote monitoring and personalized support through digital tools. This allows for real-time tracking of symptoms and proactive adjustments to treatment, potentially improving health outcomes and reducing hospital visits. Researchers are excited about this approach because it offers a more tailored and responsive way to manage COPD, addressing the needs of patients more effectively than conventional methods.

What evidence suggests that the NuvoAir Clinical Service is effective for COPD?

Research has shown that the NuvoAir Clinical Service, which participants in this trial may receive, can assist people with COPD, a lung disease that makes breathing difficult. Early findings suggest that this service helps patients stay more involved in their care, which is important for better health outcomes and lowering healthcare costs. Studies found that using the NuvoAir service significantly reduced hospital visits for COPD patients, although it did not affect the number of emergency room visits. Overall, the service appears promising in managing COPD by potentially reducing the need for hospital stays. ^{1 2 3 4 6}

Who Is on the Research Team?

Jeffrey Vanwormer

Principal Investigator

Marshfield Clinic

Are You a Good Fit for This Trial?

This trial is for people over 30 years old with COPD, including conditions like emphysema and chronic bronchitis. Participants must have been diagnosed in the last two years and need access to a smartphone or telephone.

Inclusion Criteria

I have been diagnosed with COPD in the last 2 years.

I am 30 years old or older.

You are able to use a smartphone, cell phone, or landline telephone.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive routine clinical care with the addition of the NuvoAir Clinical service, including comprehensive monitoring and personalized interventions

12 months

Virtual interactions with NuvoAir Coach and care coordinator

Follow-up

Participants are monitored for health outcomes using health insurer or provider records

12 months

What Are the Treatments Tested in This Trial?

Interventions

• NuvoAir Clinical Service

Trial Overview The study tests if the NuvoAir Clinical Service can reduce severe flare-ups, hospital visits, emergency room trips, and overall costs of care for COPD patients compared to those not using this service over a period of 12 months.

How Is the Trial Designed?

Group I: Standard Care Experimental Treatment 0 Interventions

Propensity matched controls with COPD who receive usual care.

Group II: NuvoAir Clinical service Experimental Treatment 1 Intervention

Patients with COPD receiving usual care plus NuvoAir clinical services.

NuvoAir Clinical Service is already approved in United States, European Union for the following indications:

Approved in United States as NuvoAir Clinical Service for:

• Chronic Obstructive Pulmonary Disease (COPD) management

Approved in European Union as NuvoAir Clinical Service for:

• Chronic Obstructive Pulmonary Disease (COPD) management

Who Is Running the Clinical Trial?

NuvoAir Medical PC

Lead Sponsor

Trials

2

Recruited

1,600+

Published Research Related to This Trial

A survey of 55 clinicians and 19 patients with COPD revealed that remote care delivery is widely accepted, with clinicians feeling capable of assessing symptoms and providing support for smoking cessation remotely.

Consensus was reached on the appropriateness of remote care for several activities, including collecting health information (77% agreement) and reinforcing smoking cessation (81% agreement), indicating that many aspects of COPD management can be effectively conducted online.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Specialty COPD care during COVID-19: patient and clinician perspectives on remote delivery. Wu, F., Burt, J., Chowdhury, T., et al.[2021]

An observational study found that an integrated hospital and community-based care model for COPD patients resulted in similar outcomes to previous studies, with early discharge care lasting about 9.37 days and a 21.1% readmission rate within 60 days.

The prevention of admission care lasted five to six days with a 34.1% readmission rate and a 3.8% death rate within 60 days, suggesting that this community model could effectively expand hospital-at-home services for COPD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hospital at home for chronic obstructive pulmonary disease: an integrated hospital and community based generic intermediate care service for prevention and early discharge. Davison, AG., Monaghan, M., Brown, D., et al.[2018]

The asthma/COPD service (AC service) effectively assessed around 60% of patients with airway symptoms in the northern Netherlands from 2007 to 2014, leading to improved management of asthma and COPD.

Patients who received advice from pulmonologists showed significant improvements, with a reduction in unstable COPD cases from 67% to 50% and unstable asthma cases from 3% to 24%, indicating the service's efficacy in enhancing patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Asthma/COPD service in general practice. Study into feasibility and effectiveness]. Metting, EI., Riemersma, RA., Kocks, JW., et al.[2018]

Telehealth with video components for real-time pulmonary rehabilitation is feasible and acceptable for COPD patients, suggesting it can effectively support their rehabilitation at home.

The review of seven studies indicates that telehealth can offer clinical and social benefits for COPD patients, but there remains a knowledge gap regarding its overall effectiveness and acceptance in rehabilitation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delivering Pulmonary Rehabilitation for Patients with Chronic Obstructive Pulmonary Disease at Home Using Telehealth: A Review of the Literature. Almojaibel, AA.[2020]

The establishment of an acute respiratory assessment service in a hospital significantly helps manage COPD patients by preventing unnecessary hospital admissions and providing home treatment when suitable.

An economic evaluation of the service showed that it is cost-effective, indicating that it not only improves patient care but also reduces healthcare costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The cost-effectiveness of outreach respiratory care for COPD patients. Gordois, A., Scuffham, P., Gibbons, D.[2006]

The Newcastle tertiary care multidisciplinary respiratory service effectively manages complex airway diseases like severe asthma and COPD through a comprehensive, person-centered approach known as the 'Treatable Traits' model, which has been in place for nearly 30 years.

The service includes various specialized clinics and a team of diverse healthcare professionals, ensuring tailored assessments and interventions for patients, which has been crucial in accommodating the growing demand for complex airway disease management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multidisciplinary care in chronic airway diseases: the Newcastle model. McDonald, VM., Harrington, J., Clark, VL., et al.[2022]

The implementation of a respiratory clinical-nurse-specialist-led COPD in-reach service significantly reduced the average length of hospital stay for COPD patients by 2.53 days.

This service also decreased readmission rates by an average of 4.5 per month and improved patient experience, with 17% of patients benefiting from an early assisted discharge scheme.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a specialist-nurse-led 'COPD in-reach service'. Cope, K., Fowler, L., Pogson, Z.[2016]

A chronic obstructive pulmonary disease (COPD) care service enhances timely access to follow-up care for patients transitioning from hospital to home, which is crucial for their recovery.

This service also improves patient education during the transition, helping patients better understand their condition and manage their health effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing COPD Readmission Rates: Using a COPD Care Service During Care Transitions. Portillo, EC., Wilcox, A., Seckel, E., et al.[2023]

Citations

1. 20817346.fs1.hubspotusercontent-na1.net 20817346.fs1.hubspotusercontent-na1.net/hubfs/20817346/Marketing%20Collateral/White%20paper%20clin%20service%20copd%20trials%20results%207.21.22.pdf

Initial Data Suggest NuvoAir Virtual First Clinical Service for ... Increasing patient engagement in COPD care is critical to improve patient outcomes while reducing the cost of care. An analysis by the Lancet Respira- tory ...

2. info.nuvoair.com info.nuvoair.com/hubfs/Interim-Report-NuvoAir-Clinical-Service.pdf?utm_campaign=10990876-Interim%20Report&utm_content=328516943&utm_medium=social&utm_source=linkedin&hss_channel=lcp-3677717

Interim-Report-NuvoAir-Clinical-Service.pdf These interim data indicate that NuvoAir Home. Service had a clinically significant positive impact on hospital utilization, no change in ED ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06379529?term=heart+failure

The COPD CARE Study: Evaluating the Impact of a Virtual- ... 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 ...

4. withpower.com withpower.com/trial/phase-lung-diseases-obstructive-6-2023-e071b

NuvoAir Clinical Service for COPD (PROMISE Trial) This is a 12 month study of up to 500 people with COPD to determine if the NuvoAir clinical service leads to lower rates of severe COPD exacerbations, ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05955482

NCT05955482 | Pragmatic Assessment of the NuvoAir ... To determine if use of the NuvoAir results in reduced readmissions due to COPD during the 30-day period following an exacerbation, improved health status and ...

6. nuvoair.com nuvoair.com/white-papers

Case studies & White papers Data show successful engagement and reported health outcomes with 80% reporting fewer COPD related hospitalizations since joining the NuvoAir Clinical Service.