New lung treatment aims to ease COPD breathing struggles
NCT ID NCT07051707
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a one-time procedure called lung denervation for people with COPD who are already on standard care. The goal is to see if it safely improves lung function and breathing over 6 months. About 200 adults aged 40-80 who have smoked heavily in the past will take part.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Oct 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
10 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Henry Ford Hospital - Lung and Pulmonary Care
RECRUITINGDetroit, Michigan, 48202, United States
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Mayo Clinic Jacksonville
RECRUITINGJacksonville, Florida, 32224, United States
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Medical College of Wisconsin
NOT_YET_RECRUITINGMilwaukee, Wisconsin, 53226, United States
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Ohio State University Medical Center - Ohio State Lung Center
RECRUITINGColumbus, Ohio, 43210, United States
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Penn Highlands - Lung Innovations/Clinical Research Associates
RECRUITINGDuBois, Pennsylvania, 15801, United States
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Temple University - Temple Lung Center
RECRUITINGPhiladelphia, Pennsylvania, 19140, United States
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University of Alabama-Birmingham Hospital - UAB Lung Health Center
RECRUITINGBirmingham, Alabama, 35233, United States
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University of Pittsburgh Medical Center - UMPC Comprehensive Lung Center
NOT_YET_RECRUITINGPittsburgh, Pennsylvania, 15213, United States
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Virginia Commonwealth University Health System
NOT_YET_RECRUITINGRichmond, Virginia, 23298, United States
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Wake Forest School of Medicine
NOT_YET_RECRUITINGSalem, North Carolina, 27104, United States
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