AIRFLOW-3 Study

STUDY BASICS

Are you 40-75 years old and diagnosed with COPD? You may be able to participate in study to evaluate the ability of the Nuvaira™ Targeted Lung Denervation Therapy to improve lung function and reduce the number and severity of COPD flare-ups. Eligible participants do not currently smoke. Participation in this study will last 5 years and includes multiple visits. Compensation provided.

STUDY PURPOSE

The main goal of this clinical trial is to evaluate the ability of the Nuvaira Target Lung Denervation Therapy to improve lung function and reduce the annual rate and/or severity of moderate and severe COPD exacerbations (or “flareups” characterized by increased shortness of breath, increased sputum production, and cold-like symptoms, often requiring treatment with antibiotics or steroids).

Patients with COPD have narrowed airways, making it difficult to breath air in and out of the lungs, causing a feeling of breathlessness. COPD patients also have high nerve activity in their airways causing them to narrow and create mucus. It is believed that the Target Lung Denervation (TLD) therapy will ablate the nerves. Removal of the ability of the nerve to send signals from the brain causes the airways to open and breathing to become easier, thus reducing flareups and mucus production. 

TLD therapy is done by passing a bronchoscope with a catheter inserted through it, in the lungs. The catheter delivers the type of electrical energy to the nerves located on the outside of the airways. This procedure is done once while under anesthesia.

WHAT PARTICIPANTS CAN EXPECT

Eligible participants will be randomly assigned to one of two treatment groups. One group will receive the TLD therapy, while the other group will receive placebo. Once a year has passed, the placebo group will have the opportunity to receive the TLD therapy if they wish to do so.