Targeted Lung Denervation for Patients With Moderate to Severe COPD

A prospective, sequential two phase multicenter, randomized double-blind, safety, & feasibility study. The goal of AIRFLOW-1 will be to compare two energy doses and select the optimal energy dose to be utilized in AIRFLOW-2. The goal of AIRFLOW-2 is to compare the optimal energy dose to a sham control. All subjects will be followed for a minimum of 3 years.

Inclusion criteria

• Diagnosis of COPD with 30% ≤ FEV1 < 60% and FEV1/FVC <70% (post-bronchodilator);
• Patient ≥ 40 and ≤ 75 years of age at the time of consent;
• The patient has no child bearing potential or a negative pregnancy test (serum or urine), if applicable;
• Smoking history of at least 10 pack years;
• Non-smoking for a minimum of 2 months prior to consent and agrees to continue not smoking for the duration of the study;
• Participated in a pulmonary rehabilitation program or engaged in regular physical activity under professional supervision in the past 12 months;

Exclusion criteria

• Has been less than 6 weeks following the resolution of a COPD exacerbation or active lower respiratory infection (eg. pneumonia);
• History of recurrent respiratory infections and/or COPD exacerbations (more than 2 hospitalizations within 1 year of enrollment);
• Prior lung or chest procedure (eg. lung transplant, LVRS, BLVR, lung implant, metal stent, valves, coils, median sternotomy, bullectomy, segmentectomy, or lobectomy);
• Documented history of asthma diagnosed with onset <30 years of age, cystic fibrosis, paradoxical vocal cord motion, Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis, severe interstitial lung disease or active tuberculosis;
• Pulmonary nodule requiring follow-up or intervention unless proven benign;
• Daily use of >10 mg of prednisone or its equivalent at the time of enrollment;