RecruitingNot applicable

Evaluating the Safety and Efficacy of dNerva Lung Denervation System in Patients With COPD

A Multicenter, Randomized, Study to Evaluate Safety and Efficacy After Treatment With the dNerva Lung Denervation System in Subjects With Chronic Obstructive Pulmonary Disease (COPD) (AIRFLOW-4)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether the dNerva Lung Denervation System is safe and helps people with COPD breathe better. COPD is a long-term lung disease that makes breathing hard. The study is for adults ages 40 to 80 with moderate to severe COPD who are already getting standard treatment.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 40 to 80 years old.
  • Have smoked at least 10 pack-years, such as 1 pack a day for 10 years. Have stopped smoking, vaping, and all other inhaled substances for at least 2 months, and agree not to restart during the study.
  • Have moderate to severe COPD and meet the study’s breathing test limits, including limits for trapped air in the lungs. Oxygen levels at rest must be at least 89% without added oxygen.
  • Have shortness of breath and COPD symptom scores that meet the study’s limits.
  • Have used a required combination of long-acting inhalers, with or without an inhaled steroid, for at least 2 months.
  • If able to become pregnant, have a negative pregnancy test, not be breastfeeding, and agree not to become pregnant during the study.
  • If recently in a formal lung rehabilitation program, have finished it at least 3 months earlier. If in a maintenance program, agree to continue through the 12-month visit. Prior lung rehabilitation is not required.
  • Be able to have bronchoscopy, a procedure using a scope to look inside the airways, and pause blood thinners around the procedure. Agree to all study tests, visits, and required medicines.

Who can't join

  • Have a body mass index (BMI), a measure of weight compared with height, below 18 or above 32; uncontrolled diabetes; or an implanted electronic device without medical clearance.
  • Have had 4 or more hospital stays for breathing problems in the past year, or cancer treated with radiation or chemotherapy in the past year.
  • Have another lung disease that is the main cause of symptoms, a collapsed lung in the past year, or damaged, widened airways with more than 1/3 cup of mucus coughed up daily.
  • Have high blood pressure in the lungs that meets the study’s limits, a heart attack in the past 6 months, dangerous heart rhythms, a current lack of blood flow to the heart, or certain serious heart pumping problems.
  • Have had stomach, food pipe, or pancreas surgery within 2 years, or ongoing related symptoms in the past year. Certain serious problems with stomach emptying, acid reflux, or swallowing also rule out joining.
  • Have had certain lung or chest procedures within the past year, a lung transplant, lung volume reduction surgery, or certain lung implants. A chest scan may also rule out joining because of airway size, too much lung damage, large air pockets, or a mass needing treatment.
  • Take more than 20 mg of prednisone or an equal dose of a similar steroid daily, or cannot safely receive required medicines for bronchoscopy or anesthesia despite medical treatment.
  • Have a condition that could prevent finishing the procedure or study, including an expected lifespan under 3 years, or be in another drug or treatment study with follow-up still underway.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 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.

Study sites (10)

AL

FL

MI

NC

OH

PA

VA

WI