Evaluation of the Safety and Efficacy of TLD in Patients With COPD
The purpose of this study is to confirm the safety and efficacy of the Nuvaira Lung Denervation System (Nuvaira System) in the treatment of COPD.
- Eligible Ages
- Between 40 Years and 78 Years
- Eligible Genders
- Accepts Healthy Volunteers
- Subject ≥40 and ≤78 years of age at the time of consent; - Women of child bearing potential must not be pregnant, evidenced by a negative pregnancy test (blood or urine) pre-treatment, or lactating and agree not to become pregnant for the duration of the study; - Smoking history of at least 10 pack years; - Not smoking or using any other inhaled substance (e.g., cigarettes, vaping, cannabis, pipes) for a minimum of 2 months prior to consent and agrees to not start for the duration of the study; - Subject has received a flu vaccination within the 12 months prior to the procedure or agrees to obtain vaccination once it becomes available and agrees to annual vaccinations for the duration of the study; - Resting SpO2 ≥89% on room air at the time of screening; - CAT score ≥10 at the time of screening; - Diagnosis of COPD with 30%≤ FEV1 ≤60% of predicted and FEV1/FVC <70% (post-bronchodilator); - Documented history of ≥ 2 moderate COPD exacerbations or ≥ 1 severe COPD exacerbation leading to hospitalization in the 12 months prior to consent with at least one exacerbation occurring while the subject was on optimal medical care (taking LAMA and a LABA as regular respiratory maintenance medication); - Subject is on optimal medical care at the time of consent; - If subject has participated in a formal pulmonary rehabilitation program recently, program completion must have occurred ≥3 months prior to consent; if in a maintenance program, subject agrees to continue their current program through their 12-month follow-up visit; - Subject is a candidate for bronchoscopy in the opinion of the physician or per hospital guidelines; - The subject is willing, able and agrees to complete all protocol required baseline and follow-up testing assessments including taking certain medications (e.g., azithromycin, prednisolone/prednisone); - Subject has provided written informed consent using a form that has been reviewed and approved by the Institutional Review Board (IRB)/Ethics Committee (EC).
- Body Mass Index <18 or >35; - Subject has an implantable electronic device and has not received appropriate medical clearance; - Uncontrolled diabetes as evidenced by an HbA1c >7 %; - Pulmonary nodule thought to be at high risk of malignancy; - Malignancy treated with radiation or chemotherapy within 2 years of consent; - Four (4) or more respiratory related hospitalizations within 1 year of consent; - Asthma as defined by the current Global Initiative for Asthma (GINA) guidelines; - Subject diagnosed with a dominant non-COPD lung disease or condition which affects the lungs (e.g., cystic fibrosis, paradoxical vocal cord motion, eosinophilic granulomatosis with polyangiitis (EGPA), allergic bronchopulmonary aspergillosis, interstitial lung disease or active tuberculosis) or has a documented medical history of pneumothorax within 2 years of consent; - Clinically relevant bronchiectasis, defined as severe single lobe or multilobar broncial wall thickening associated with airway dilation on CT scan leading to cough and tenacious sputum on most days; - Known pre-existing diagnosis of pulmonary hypertension, defined as clinical evidence of pulmonary hypertension (i.e. cardiovascular function impairment including peripheral edema) and a sustained elevation of the mean pulmonary artery pressure ≥25 mmHg at rest by right heart catheterization or estimated right ventricular systolic pressure >40 mmHg by echocardiogram; - Myocardial infarction within last 6 months, EKG with evidence of life threatening arrhythmias or acute ischemia, pre-existing documented evidence of an LVEF <45%, stage C or D (ACC/AHA) or Class III or IV (NYHA) congestive heart failure, or any other past or present cardiac findings that make the subject an unacceptable candidate for a bronchoscopic procedure utilizing general anesthesia; - Subjects who have had abdominal surgical procedure(s) on the stomach, esophagus or pancreas performed ≤2 years of consent or have ongoing related symptoms within the past year; - Subjects with symptomatic gastric motility disorder(s) (e.g., gastroparesis) as evidenced by a GCSI score ≥18.0 or with severe GERD (e.g., refractory heartburn, endoscopic esophagitis) or severe dysphagia (e.g., esophageal stricture, achalasia, esophageal spasm); - The subject has any disease or condition that might interfere with completion of a procedure or this study (e.g., structural esophageal disorder, life expectancy <3 years); - Prior lung or chest procedure (e.g., lung transplant, LVRS, BLVR, lung implant, metal stent, valves, coils, median sternotomy, bullectomy, lobectomy or segmentectomy or other interventional lung procedure performed ≤1 year of consent); NOTE: Segmentectomy for benign lesion or segmentectomy for non-recurrent cancer ≥2 years is allowed. Vascular stents allowed if implanted ≥3 months and ≥5 mm away from the anticipated treatment location(s). Subjects with explanted lung valve(s) allowed if ≥3 months and meet all other enrollment criteria. - Daily use of >10 mg of prednisone or its equivalent at the time of consent; - Recent (within 3 months of consent) opioid use; - Known contraindication or allergy to medications required for bronchoscopy or general anesthesia (e.g., lidocaine, atropine, propofol, sevoflurane) that cannot be medically controlled; - Baseline chest CT scan reveals bronchi anatomy cannot be fully treated with available catheter sizes, presence of severe emphysema >50%, lobar attenuation area or severe bullous disease (>1/3 hemithorax) (as determined by the CT core lab using a single density mask threshold of -950 HU) or site discovery of a mass that requires treatment; - Subject is currently enrolled in another interventional clinical trial that has not completed follow-up.
- Study Type
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Subjects will be randomized with equal allocation (1:1) into two arms: TLD therapy plus optimal medical care (Active Treatment) and optimal medical care (Sham Control). Randomization of subjects will be stratified based on investigational site, participation in a pulmonary rehabilitation maintenance program and baseline use of an inhaled corticosteroid at the time of enrollment.
- Primary Purpose
- Double (Participant, Outcomes Assessor)
- Masking Description
- Subject and assessor double-blinding will be maintained through 1 year post-procedure.
|Target Lung Denervation (TLD) with the Nuvaira Lung Denervation System (RF energy delivered) and optimal medical care for COPD.||
|Sham Targeted Lung Denervation (TLD) procedure with the Nuvaira Lung Denervation System (catheter placement and balloon deployment in all treatment locations, no RF energy delivered) and optimal medical care for COPD.||
- Nuvaira, Inc.
Study ContactDelanie Reller
The primary objective of this study is to demonstrate the superiority of treatment with the Nuvaira Lung Denervation System (Active Treatment arm) compared to a sham procedure (Sham Control arm) to decrease moderate or severe exacerbations in subjects with COPD on optimal medical care. The secondary objective is to compare long-term safety, and other efficacy assessments between the Active Treatment arm and the Sham Control arm.