Evaluating the Safety and Efficacy of TLD in Patients With COPD
NCT ID: NCT07051707
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
PHASE3
400 participants
INTERVENTIONAL
2026-02-15
2029-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The secondary objective is to compare other efficacy assessments between the Treatment arm and the Control arm, and to confirm the safety profile of lung denervation.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
Participants randomized to Treatment: will undergo TLD treatment with the dNerva Lung Denervation System while continuing the standard medical care that they were on prior to randomization and followed for 2 years or until study closure, whichever is earlier.
Participants randomized to Control: will continue the standard medical care that they were on prior to randomization, followed for 1 year, then given the option to receive TLD treatment. Whether treated or not, participants will continue follow-up for 1 year or until study closure, whichever is earlier.
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Continuing the standard medical care prior to randomization
Continuing standard of care COPD maintenance medication that minimally includes LABA/ICS, LAMA/LABA or LABA/LAMA/ICS.
Standard medical care
Continuing standard of care COPD maintenance medication that minimally includes LABA/ICS, LAMA/LABA or LABA/LAMA/ICS.
Targeted Lung Denervation (TLD) treatment with standard medical care prior to randomization
Targeted Lung Denervation (TLD)Therapy is a bronchoscopically guided, minimally invasive procedure using the Nuvaira™ Lung Denervation System while taking regular maintenance medication that minimally includes a long acting bronchodilator with or without a corticosteroid.
Targeted Lung Denervation (TLD)
Targeted Lung Denervation (TLD)Therapy is a bronchoscopically guided, minimally invasive procedure using the Nuvaira™ Lung Denervation System.
Standard medical care
Continuing standard of care COPD maintenance medication that minimally includes LABA/ICS, LAMA/LABA or LABA/LAMA/ICS.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Targeted Lung Denervation (TLD)
Targeted Lung Denervation (TLD)Therapy is a bronchoscopically guided, minimally invasive procedure using the Nuvaira™ Lung Denervation System.
Standard medical care
Continuing standard of care COPD maintenance medication that minimally includes LABA/ICS, LAMA/LABA or LABA/LAMA/ICS.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 at the time of screening?
* mMRC ≥ 2; CAT score ≥ 10 at the time of screening?
* Diagnosis of moderate to severe COPD as defined by FEV1/FVC \< 70% (post-bronchodilator), FEV1 25-\<60% 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 a long-acting bronchodilator, (LABA, LAMA, LABA/ICS or LAMA/LABA) for at least 2 months prior to consent?
* If participant has participated in a formal pulmonary rehabilitation program recently, program completion must have occurred ≥3 months prior to consent; if in a maintenance program, participant 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
* 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 started taking a monoclonal antibody (mAb), or a PDE3/PDE4 inhibitor less than 6 months prior to screening. (Participants on these medications for less than 6 months must wait until 6 months has passed prior to screening.)?
* Participant is currently enrolled in another drug or interventional clinical trial that has not completed follow-up?
40 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Alabama at Birmingham
OTHER
Temple Health
UNKNOWN
Ohio State University
OTHER
Honor Health - Clinical Trials
UNKNOWN
Medical College of Wisconsin
OTHER
University of Pittsburgh Medical Center
OTHER
Royal Brompton & Harefield NHS Foundation Trust
OTHER
Nuvaira, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Prof. Gerard Criner, MD
Role: PRINCIPAL_INVESTIGATOR
Temple Health
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
D0836
Identifier Type: -
Identifier Source: org_study_id