Official Title 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 (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.

Age Range

40 and up

Official Title Extracellular vesicles and the development of COPD

Purpose

The study is being done to learn more about how certain smokers develop COPD, chronic obstructive pulmonary disease. By studying microscopic particles (extracellular vesicles) in the blood and lung fluid from smokers we can learn more about this process. This information could lead to better understanding of how smoking damages the lungs and could ultimately help design treatments for people with or at risk for COPD

Could this study be right for you?

• 21 years of age and older
• Current Smoker with at least 10 pack year history
• With or without diagnosis of COPD
• Willing to participate in bronchoscopy procedure
• Not currently diagnosed interstitial lung disease (i.e. sarcoidosis, idiopathic pulmonary fibrosis), lung cancer, primary pulmonary hypertension or have active cardiac disease

Age Range

21 and up

Official Title Biomarkers of Sickle Cell Lung Disease -BOLD

Purpose

This is a study to determine risk factors for developing lung disease in children with sickle cell disease (SCD). Specifically we are researching factors that lead to the development of Acute Chest Syndrome, a pneumonia-like illness that affects many children with SCD.

Could this study be right for you?

• Diagnosis of Sickle Cell Disease (SCD)
• Under the age of 19