A Multicenter, Randomized, Sham-controlled Study to Evaluate Safety and Efficacy After Treatment with the Nuvaira™ Lung Denervation System in Patients with Chronic Obstructive Pulmonary Disease (COPD)

Nuvaira, Inc.33 sites in 6 countries464 target enrollmentMay 23, 2019

ConditionsCOPD

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: COPD
Sponsor: Nuvaira, Inc.
Enrollment: 464
Locations: 33
Primary Endpoint: Moderate or severe COPD exacerbations
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Detailed Description

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.

Registry

clinicaltrials.gov

Start Date

May 23, 2019

End Date

September 2028

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Nuvaira, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subject ≥40 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 25%≤ FEV1 ≤80% of predicted, PaCO2 ˂ 50 (if FEV1 ˂30%) 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, or scheduled SABA or SAMA instead of either a LAMA or LABA, not both, as regular respiratory maintenance medication);
•Subject is on optimal medical care at the time of consent;

Exclusion Criteria

•Body Mass Index \<18 or \>35;
•Subject has an implantable electronic device and has not received appropriate medical clearance;
•Uncontrolled diabetes in the opinion of the investigator;
•Malignancy treated with radiation or chemotherapy 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 affecting the lungs, which is the main driver of the subjects clinical symptoms (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 1 year 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;
•Pre-existing diagnosis of pulmonary hypertension, clinical evidence of pulmonary hypertension (e.g., cardiovascular function impairment including peripheral edema) and mPAP ≥25 mmHg at rest by right heart catheterization (or estimated right ventricular systolic pressure \>50 mmHg by echocardiogram if no previous right heart catheterization);
•Myocardial infarction within last 6 months, EKG with evidence of life threatening arrhythmias or acute ischemia, pre-existing documented evidence of an LVEF \<40%, 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;
•Surgical procedure(s) on the stomach, esophagus or pancreas performed ≤2 years of consent or ongoing related symptoms within the past year;

Outcomes

Primary Outcomes

Moderate or severe COPD exacerbations

Time Frame: Randomization to 12 Months

A COPD exacerbation will be defined as a complex of respiratory events/symptoms (increase or new onset) of more than one of the following: cough, sputum, wheezing, dyspnea or chest tightness with at least one symptom lasting three days requiring treatment with antibiotics and/or systemic steroids (moderate exacerbation) and/or hospital admission (severe exacerbation).

Secondary Outcomes

Change in Short Form Health Survey (SF-36) total score(Randomization to 12 Months)
Time to first severe COPD exacerbation(Randomization to 12 Months)
Change in St. George's Respiratory Questionnaire COPD Version (SGRQ-C) Total score(Randomization to 12 months)
Change in FVC(Randomization to 12 Months)
Change in FEV1(Randomization to 12 months)
Transition Dyspnea Index (TDI)(Randomization to 12 months)
Time to first severe COPD exacerbation (Subgroup)(Randomization to 12 months)
Time to first respiratory-related hospitalization(Randomization to 12 Months)
Change in RV(Randomization to 12 months)
CAT responders(Randomization to 12 Months)