A Treatment Study For COPD
Purpose
The purpose of this research study is to evaluate the safety and efficacy of the Nuvaira System, which is made by Nuvaira, Inc., for Targeted Lung Denervation (TLD) Therapy.
The primary purpose of conducting this study is to see if TLD Therapy in addition to optimal medical care (daily breathing medications you have been prescribed by your doctor) is better at reducing a moderate or severe worsening of symptoms (known as an COPD flare-ups or exacerbations) and related hospitalizations than optimal medical care (daily breathing medications you have been prescribed by your doctor) alone.
Could this study be right for you?
Inclusion Criteria:
• Between 40 and 75 years of age
• Non-smoking for a minimum of 2 months prior to consent and agrees to not smoke for the duration of the study
• Diagnosis of COPD with 30% ≤ FEV1 <60% of predicted and FEV1/FVC <70% (post-bronchodilator)
• SpO2 of at least 89% on room air at the time of screening
• Has a documented history of having minimally been taking a regular respiratory maintenance medication for at least 12 months at the time of consent; medications will be reviewed by study team
• If you have participated in a formal pulmonary rehabilitation program recently, program completion should have occurred more than 3 months prior to consent; if in a maintenance program, you will agree to continue your current program through your 12-month follow-up visit;
• Additional criteria will be reviewed by the study team
Involvement in this study will last approximately 62 months.