NCT07051707

Evaluating the Safety and Efficacy of dNerva Lung Denervation System in Patients With COPD

A Multicenter, Randomized, Study to Evaluate Safety and Efficacy After Treatment With the dNerva Lung Denervation System in Subjects With Chronic Obstructive Pulmonary Disease (COPD) (AIRFLOW-4)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Nuvaira, Inc. · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The dNerva Lung Denervation System is one-time treatment intended to improve breathing in Chronic Obstructive Pulmonary Disease (COPD) patients on standard medical care. The purpose of this study is to confirm the safety and efficacy of the Nuvaira Lung Denervation System in the treatment of COPD.

Detailed description

The primary objective of this study is to demonstrate the superiority of treatment with the dNerva Lung Denervation System on top of standard medical care (Treatment arm) compared to standard medical care alone (Control arm) to improve lung function in COPD participants with high RV and low emphysema. The secondary objective is to compare other efficacy assessments between the Treatment arm and the Control arm, and to confirm the safety profile of lung denervation.

Conditions

• COPD
• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DEVICE	Targeted Lung Denervation (TLD)	Targeted Lung Denervation (TLD)Therapy is a bronchoscopically guided minimally invasive one-time treatment using the dNerva Lung Denervation System.

Timeline

• Start date: 2026-02-15
• Primary completion: 2028-04-30
• Completion: 2029-10-31
• First posted: 2025-07-04
• Last updated: 2026-02-27

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated device study