TLD for COPD

(AIRFLOW-3 Trial)

Not currently recruiting at 34 trial locations

Overseen By Ken Yoneda, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Nuvaira, Inc.

Must be taking: LAMA, LABA, SABA, SAMA

Must not be taking: Opioids, Prednisone

Disqualifiers: Asthma, Diabetes, Malignancy, others

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

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 aims to test the safety and effectiveness of the Nuvaira Lung Denervation System, a new treatment for chronic obstructive pulmonary disease (COPD). Participants will receive either the actual treatment, which uses energy to target nerves in the lungs, or a sham procedure with no active treatment but standard COPD care. The trial seeks individuals diagnosed with COPD who have experienced at least two flare-ups in the last year and have not smoked in the past two months. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research in COPD treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that participants must be on optimal medical care for COPD. You may need to continue certain medications like azithromycin or prednisolone/prednisone as part of the study.

What prior data suggests that the Nuvaira Lung Denervation System is safe for treating COPD?

Research has shown that the Nuvaira Lung Denervation System is generally safe for people with COPD (Chronic Obstructive Pulmonary Disease). Studies have found it to be safe for up to three years, with no serious side effects reported later. This suggests the treatment remains safe over time.

The system uses radio waves to target nerves in the lungs, which can help improve breathing. Overall, evidence supports the safety of the Nuvaira System for people with COPD, with no major long-term safety concerns reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for COPD, like bronchodilators and corticosteroids, work by opening airways or reducing inflammation. But the Nuvaira Lung Denervation System stands out because it targets the nerves in the lungs that contribute to airway constriction. This system uses radiofrequency (RF) energy to interrupt nerve signals, potentially reducing symptoms more effectively. Researchers are excited because this approach offers a novel way to manage COPD, focusing on nerve activity rather than just treating symptoms, which could lead to longer-lasting relief for patients.

What evidence suggests that the Nuvaira Lung Denervation System is effective for COPD?

Research has shown that the Nuvaira Lung Denervation System can aid people with COPD, a lung disease that makes breathing difficult, by improving their ability to breathe. In this trial, participants will join different arms. One arm will receive the active treatment with the Nuvaira Lung Denervation System, which studies have shown lowers the risk of severe COPD flare-ups over two years and helps maintain stable lung function. Another study demonstrated that the decline in lung function slowed over three years after using this system. These findings suggest that the Nuvaira System may be a good option for managing COPD symptoms and maintaining lung health. ^{1 2 5 6 7}

Who Is on the Research Team?

Frank Sciurba, MD

Principal Investigator

University of Pittsburgh Medical Center

Prof. Dirk-Jan Slebos, MD, PhD

Principal Investigator

University Medical Center Groningen

Are You a Good Fit for This Trial?

Adults over 40 with COPD who've had at least 2 moderate or 1 severe exacerbation in the past year, despite optimal medical care. They must not smoke, have a CAT score ≥10, FEV1 between 25-80% predicted, and agree to flu vaccinations. Excluded are those with certain other diseases or conditions that could affect study participation or those on high doses of steroids.

Inclusion Criteria

I have COPD with specific lung function test results.

I can stop taking blood thinners for a lung exam.

CAT score ≥10 at the time of screening;

Exclusion Criteria

I have been diagnosed with high blood pressure in the lungs.

I had a lung or chest surgery less than a year ago, with any metal placed at least 5cm away from where I'll be treated.

I have severe stomach or swallowing problems.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the Nuvaira Lung Denervation System treatment or a sham procedure

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Nuvaira Lung Denervation System

Trial Overview The trial is testing the Nuvaira Lung Denervation System's safety and effectiveness for treating COPD compared to optimal medical care alone. It involves a procedure called Targeted Lung Denervation (TLD) which aims to reduce nerve signals that cause airway constriction.

How Is the Trial Designed?

Group I: Active Treatment Experimental Treatment 2 Interventions

Target Lung Denervation (TLD) with the Nuvaira Lung Denervation System (RF energy delivered) and optimal medical care for COPD.

Group II: Sham Control Placebo Group 1 Intervention

Sham Targeted Lung Denervation (TLD) procedure with the Nuvaira Lung Denervation System (catheter placement and balloon deployment in all treatment locations, no RF energy delivered) and optimal medical care for COPD.

Who Is Running the Clinical Trial?

Nuvaira, Inc.

Lead Sponsor

Trials

6

Recruited

630+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07051707

NCT07051707 | Evaluating the Safety and Efficacy of TLD ... The dNerva Lung Denervation System is one-time treatment intended to improve breathing in Chronic Obstructive Pulmonary Disease (COPD) patients on standard ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7652218/

Two-Year Outcomes for the Double-Blind, Randomized ... Two-year outcomes for the double-blind, randomized, sham-controlled study of targeted lung denervation in patients with moderate to severe COPD: AIRFLOW-2

3. nuvaira.com nuvaira.com/clinical-evidence/

Clinical Evidence The clinical impact of TLD is durable, as it is found to reduce the risk of serious COPD adverse events over 2 years with stabilized lung function. The ...

4. resmedjournal.com resmedjournal.com/article/S0954-6111(21)00312-7/fulltext

Rate of lung function decline slows in the 3 years after ... Rate of lung function decline slows in the 3 years after targeted lung denervation in COPD. Jorine E. Hartman. Jorine E.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32054473/

Design for a multicenter, randomized, sham-controlled ... Design for a multicenter, randomized, sham-controlled study to evaluate safety and efficacy after treatment with the Nuvaira® lung denervation system in ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7893728/

Safety of denervation following targeted lung ... TLD in COPD patients demonstrated a positive safety profile out to 3 years, with no late-onset serious adverse events related to denervation therapy.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02058459

Study Details | NCT02058459 | Targeted Lung Denervation ... The purpose of this study is to evaluate safety of Targeted Lung Denervation (or TLD) in patients suffering from moderate to severe COPD. It is hypothesized ...