TLD for COPD

(AIRFLOW-3 Trial)

Recruiting at 33 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

464 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to confirm the safety and efficacy of the Nuvaira Lung Denervation System (Nuvaira System) in the treatment of COPD.

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 data supports the effectiveness of the treatment Nuvaira Lung Denervation System for COPD?

Research shows that the Nuvaira Lung Denervation System, a treatment for COPD, can reduce symptoms and the frequency of moderate-to-severe exacerbations (worsening of symptoms). Studies have demonstrated that this treatment is safe and can lead to fewer respiratory issues and hospitalizations compared to standard therapy alone. ^{1 2 3 4 5}

Is the Nuvaira Lung Denervation System safe for humans?

Research shows that the Nuvaira Lung Denervation System, also known as Targeted Lung Denervation (TLD), is generally safe for people with COPD. Studies found that patients treated with TLD had fewer respiratory problems and hospitalizations compared to those who did not receive the treatment. ^{2 3 4 5 6}

How is the Nuvaira Lung Denervation System treatment different from other COPD treatments?

The Nuvaira Lung Denervation System is unique because it uses a bronchoscopic procedure to target and ablate (destroy) parasympathetic nerves around the main bronchi, which can help manage COPD symptoms, particularly in patients with chronic bronchitis. This approach is different from other treatments like lung volume reduction surgery or endoscopic lung volume reduction, which focus on reducing lung volume to improve breathing. ^{7 8 9 10 11}

Research Team

Frank Sciurba, MD

Principal Investigator

University of Pittsburgh Medical Center

Prof. Dirk-Jan Slebos, MD, PhD

Principal Investigator

University Medical Center Groningen

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. England pubmed.ncbi.nlm.nih.gov

Design for a multicenter, randomized, sham-controlled study to evaluate safety and efficacy after treatment with the Nuvaira® lung denervation system in subjects with chronic obstructive pulmonary disease (AIRFLOW-3). [2020]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Crossover Patient Outcomes for Targeted Lung Denervation in Moderate to Severe Chronic Obstructive Pulmonary Disease: AIRFLOW-2. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Feasibility, effectiveness, and safety of a novel cryo-balloon targeted lung denervation technique in an animal model. [2021]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Long-term safety of bilateral targeted lung denervation in patients with COPD. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Safety and Adverse Events after Targeted Lung Denervation for Symptomatic Moderate to Severe Chronic Obstructive Pulmonary Disease (AIRFLOW). A Multicenter Randomized Controlled Clinical Trial. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Safety of denervation following targeted lung denervation therapy for COPD: AIRFLOW-1 3-year outcomes. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Supported and unsupported arm exercise capacity following lung volume reduction surgery: a pilot study. [2017]

8. Japan pubmed.ncbi.nlm.nih.gov

[Bronchoscopic treatments for COPD]. [2016]

9. Egypt pubmed.ncbi.nlm.nih.gov

Update on Nonsurgical Lung Volume Reduction Procedures. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Correction of single-breath helium lung volumes in patients with airflow obstruction. [2019]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Long-Term Results After Lung Volume Reduction Surgery: A Single Institution's Experience. [2019]