No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
40 – 80
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
200 (estimated)
Sponsor
Nuvaira, Inc. · Industry
Who this trial is looking for
This trial is looking for adults with chronic obstructive pulmonary disease (COPD) who have been receiving standard medical care. Participants will undergo a one-time procedure to help improve their breathing.
Are You a Good Fit for This Trial?
Must be takingLABA/ICSLAMA/LABALAMA/LABA/ICS
Rules you outPulmonary hypertensionMyocardial infarctionGastric motility disorder
You may be able to join if
I am between 40 and 80 years old.
I have been diagnosed with moderate to severe COPD.
I have a smoking history of at least 10 pack years.
I have not smoked or used inhaled substances for at least 2 months.
I am on standard medical care for COPD.
I have completed a pulmonary rehabilitation program at least 3 months ago or am currently continuing my program.
My resting blood oxygen level is at least 89%.
I agree to complete all required tests and assessments.
You may not be able to join if
I have a body mass index (BMI) less than 18 or greater than 32.
I have had 4 or more hospitalizations for respiratory issues in the past year.
I have been diagnosed with another serious lung disease.
I have had a heart attack in the last 6 months.
I have recently undergone surgery on my stomach or pancreas.
I have a known allergy to required medications for the procedure.
I have daily mucous expectoration that is clinically relevant.
I am currently enrolled in another clinical trial.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
The dNerva Lung Denervation System is one-time treatment intended to improve breathing in Chronic Obstructive Pulmonary Disease (COPD) patients on standard medical care. The purpose of this study is to confirm the safety and efficacy of the Nuvaira Lung Denervation System in the treatment of COPD.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* ≥ 40 and ≤ 80 years of age at the time of consent.
* Women of childbearing 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 a…
Inclusion Criteria:
* ≥ 40 and ≤ 80 years of age at the time of consent.
* Women of childbearing 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.
* Resting SpO2 ≥ 89% on room air.
* MMRC ≥ 2; CAT score ≥ 10.
* Diagnosis of moderate to severe COPD as defined by FEV1/FVC \< 70% (post-bronchodilator), 25% ≤ FEV1 ≤ 70% predicted, and PaCO2 \< 50 (if FEV1 \< 30%).
* RV ≥ 175% of predicted and RV/TLC \> 55% (post-bronchodilator).
* Participant is on standard medical care, defined as a minimum of therapy with LABA/ICS, LAMA/LABA, or LAMA/LABA/ICS for at least 2 months prior to 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; NOTE: Prior participation in a pulmonary rehabilitation program is not required for inclusion in the study.
* Participant is a candidate for bronchoscopy in the opinion of the investigator or per hospital guidelines and is able to discontinue blood thinning medication peri-procedurally.
* Participant is able and agrees to complete all protocol required baseline and follow up tests and assessments including taking certain medications (e.g., azithromycin, prednisolone/prednisone).
Exclusion Criteria:
* Body Mass Index (BMI) \<18 or \>32.
* Participant has an implantable electronic device and has not received appropriate medical clearance.
* Uncontrolled diabetes in the opinion of the investigator.
* 4 or more respiratory related hospitalizations within 1 year of consent.
* Malignancy treated with radiation or chemotherapy within 1 year of consent.
* Participant diagnosed with a dominant non-COPD lung disease, or condition affecting the lungs, which is the main driver of the participant's 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 Asthma) or has a documented medical history of pneumothorax within 1 year of consent.
* Clinically relevant bronchiectasis, defined as \> 1/3 cup mucous expectoration daily.
* 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, evidence of life-threatening arrhythmias or acute ischemia, pre-existing documented evidence of a LVEF \< 40%, stage C or D (ACC/AHA) or Class III or IV (NYHA) congestive heart failure.
* Surgical procedure(s) on the stomach, esophagus or pancreas performed ≤2 years of consent, or ongoing related symptoms within the past year.
* Symptomatic gastric motility disorder(s) (e.g., gastroparesis) as evidenced by GCSI score ≥18.0, severe uncontrolled GERD (e.g., refractory heartburn, endoscopic esophagitis) or severe dysphagia (e.g., esophageal stricture, achalasia, esophageal spasm). NOTE: Participants with a hiatal hernia are allowed if Participant meets all other enrollment criteria.
* 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., BLVR explant procedure, median sternotomy, bullectomy, lobectomy, segmentectomy or other interventional lung or chest procedure) performed ≤1 year of consent? Participants with lung transplant, BLVR valves, LVRS, metal stents within 5cm of the anticipated treatment location; presence of lung volume reduction valves, coils or other lung implants.
* Daily use of \>20 mg of prednisone or its equivalent at the time of consent.
* 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 bronchial anatomy cannot be treated with available catheter sizes; presence of whole lung emphysema \>20% (-950 HU), single lung emphysema \>26% (-950 HU), severe bullous disease (\>1/3 hemithorax) or discovery of a mass that requires treatment.
* Participant is currently enrolled in another drug or interventional clinical trial that has not completed follow-up.
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