Evaluation of the Safety and Efficacy of TLD in Patients With COPD

Clinical Trial ID: NCT03639051

Description

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.

The primary objective of this study is to evaluate the efficacy of targeted lung denervation (TLD) in addition to optimal medical care to reduce moderate or severe exacerbation's and related hospitalizations, compared with optimal medical care alone, in patients with chronic obstructive pulmonary disease (COPD). The secondary objective is to evaluate the long-term safety and other efficacy assessments of targeted lung denervation (TLD) in addition to optimal medical care compared with optimal medical care alone.


Criteria

Inclusion Criteria: - Patient ≥40 and ≤75 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; - Non-smoking (e.g., cigarettes, vaping, cannabis, pipes) for a minimum of 2 months prior to consent and agrees to not smoke for the duration of the study; - Patient has received a flu vaccination within the 12 months prior to consent and agrees to annual vaccinations for the duration of the study; - SpO2 ≥89% on room air at the time of screening; - CAT score ≥15 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; - Patient has a documented history of having minimally been taking a LAMA and a LABA as regular respiratory maintenance medication for ≥12 months at the time of consent; - If patient has participated in pulmonary rehabilitation, program must have been completed ≥3 months prior to consent and patient agrees to continue current level of activity through their 12-month follow-up visit, if applicable; - Patient is a candidate for bronchoscopy in the opinion of the physician or per hospital guidelines; - The patient is willing, able and agrees to complete all protocol required baseline and follow-up testing assessments including taking certain medications; - Patient has provided written informed consent using a form that has been reviewed and approved by the Institutional Review Board (IRB)/Ethics Committee (EC). Exclusion Criteria: - Body Mass Index <18 or >35; - Patient has an implantable electronic device; - Uncontrolled diabetes as evidenced by an HbA1c >7 %; - Pulmonary nodule thought to be at high risk of malignancy or a malignancy treated with radiation or chemotherapy within the last 2 years; - More than 3 respiratory related hospitalization within 1 year of consent; - Documented diagnosis of asthma or failure of asthma screening assessment; - Patient has been previously diagnosed with a non-COPD lung disease (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; - Clinically relevant bronchiectasis diagnosed by CT whose current treatment would interfere with outcome assessments; - Known pre-existing diagnosis of pulmonary hypertension, defined as a sustained elevation of the mean pulmonary artery pressure greater than or equal to 25mm Hg at rest by right heart catheterization or estimated by echocardiogram to be greater than 40 mm Hg; - 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 patient an unacceptable candidate for a bronchoscopic procedure utilizing general anesthesia; - Known pre-existing gastrointestinal motility disorder (e.g., achalasia, gastroparesis, hiatal hernia, irritable bowel syndrome) or previous abdominal surgical procedure on stomach, esophagus or pancreas (e.g., esophagectomy, gastrostomy, gastrectomy, bariatric surgery, fundoplication, vagotomy); - Patients with a GCSI total symptom score ≥18.0 (sum of PAGI-SYM questions 1-9) prior to treatment; - The patient 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); NOTE: segmentectomy for benign lesion or segmentectomy for non-recurrent cancer ≥2 years are allowed. - Daily use of >10 mg of prednisone or its equivalent at the time of consent; - Recent (<3 months ago) 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% (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; - In the opinion of the treating investigator, use of the Nuvaira System is not technically feasible due to patient anatomy or other clinical finding (e.g., acute pneumothorax, pleural effusion); - Patient is currently enrolled in another clinical trial that has not completed follow-up.

  • Start Date

    2019-05-23

  • Last Updated

    2019-08-01

  • Sponsor

    Nuvaira, Inc.

  • Condition Name

    COPD

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