Actively Recruiting
A Multicenter, Randomized Study Evaluating Safety and Efficacy of the dNerva Lung Denervation System in Adults with COPD (AIRFLOW-4)
Led by Nuvaira, Inc. · Updated on 2026-04-28
200
Participants Needed
10
Research Sites
78 weeks
Total Duration
On this page
Sponsors
N
Nuvaira, Inc.
Lead Sponsor
T
Temple Health
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of the dNerva Lung Denervation System as a one-time treatment to improve breathing in adults with Chronic Obstructive Pulmonary Disease (COPD). The study compares adding this new device treatment to standard COPD medical care versus standard care alone in patients who have high residual lung volume and low emphysema. The goal is to see if lung function improves and to confirm the safety of the lung denervation procedure. Participants are randomly assigned to one of two groups: one group receives the Targeted Lung Denervation (TLD) therapy using the dNerva system along with their usual COPD medications, and the other group continues with their standard medical care without additional intervention. The TLD therapy is a minimally invasive bronchoscopic treatment done once. Those in the control group who complete one year of follow-up may opt to receive the TLD treatment afterward and will be monitored for an additional year. During the study, participants will undergo various tests and assessments including lung function measurements like FEV1 at 6 and 12 months, lung volume changes, breathing difficulty scores, quality of life questionnaires, and tracking of COPD flare-ups over a year. Safety will be closely monitored throughout. The study lasts at least one year for primary follow-up, with some participants followed longer if they crossover to receive the treatment after one year.
CONDITIONS
Brief Title
Evaluating the Safety and Efficacy of dNerva Lung Denervation System in Patients With COPD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 40 to 80 years at the time of consent
- Women of childbearing potential must have a negative pregnancy test before treatment and agree not to become pregnant during the study
- Smoking history of at least 10 pack years
- Not smoking or using inhaled substances for at least 2 months before consent and agree to remain non-smoking during the study
- Resting oxygen saturation (SpO2) of 89% or higher on room air
- Moderate to severe COPD diagnosis with specific lung function criteria (FEV1/FVC < 70%, FEV1 between 25% and 70% predicted, PaCO2 < 50 if FEV1 < 30%)
- Residual lung volume (RV) 175% or higher of predicted and RV/total lung capacity (TLC) over 55%
- On standard COPD medical care (LABA/ICS, LAMA/LABA, or LAMA/LABA/ICS) for at least 2 months before consent
- If participated in pulmonary rehabilitation, completed formal program at least 3 months before consent or agrees to continue maintenance program through 12-month follow-up
- Candidate for bronchoscopy and able to stop blood thinning medication if needed
- Able and willing to complete all required tests and assessments including certain medications
You will not qualify if you...
- Body Mass Index (BMI) less than 18 or greater than 32
- Has an implantable electronic device without proper medical clearance
- Uncontrolled diabetes
- Four or more respiratory-related hospitalizations within 1 year before consent
- Recent malignancy treated with radiation or chemotherapy within 1 year
- Dominant lung disease other than COPD or lung condition affecting symptoms (e.g., cystic fibrosis, asthma, tuberculosis)
- Clinically relevant bronchiectasis with daily mucous expectoration over one-third cup
- Pulmonary hypertension or signs of heart failure with certain heart function thresholds
- Recent heart attack, dangerous heart rhythms, or severe heart failure
- Stomach, esophagus, or pancreas surgery within 2 years or ongoing related symptoms
- Severe stomach motility disorders or severe acid reflux and swallowing problems
- Any disease or condition interfering with study or procedure completion
- Prior lung or chest surgery or lung implants within specified timeframes
- Daily use of prednisone over 20 mg at consent
- Allergies or contraindications to bronchoscopy or anesthesia medications
- Chest CT showing unsuitable lung anatomy for treatment
- Currently enrolled in another drug or interventional clinical trial with ongoing follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - One-time treatment with ongoing standard care
Participants in the treatment arm receive a one-time bronchoscopically guided minimally invasive lung denervation treatment with the dNerva Lung Denervation System in addition to their standard COPD medical care. Participants in the control arm continue their standard COPD medical care without intervention.
1 treatment visit (in-person)
Duration - Up to 12 months
Participants are monitored to assess lung function, symptoms, and safety outcomes for up to 12 months following treatment or continuation of standard care. Participants in the control arm have the option for crossover treatment after 1 year.
Regular follow-up visits over 12 months
Trial Site Locations
Total: 10 locations
1
University of Alabama-Birmingham Hospital - UAB Lung Health Center
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32224
Actively Recruiting
3
Henry Ford Hospital - Lung and Pulmonary Care
Detroit, Michigan, United States, 48202
Actively Recruiting
4
Wake Forest School of Medicine
Salem, North Carolina, United States, 27104
Not Yet Recruiting
5
Ohio State University Medical Center - Ohio State Lung Center
Columbus, Ohio, United States, 43210
Actively Recruiting
6
Penn Highlands - Lung Innovations/Clinical Research Associates
DuBois, Pennsylvania, United States, 15801
Actively Recruiting
7
Temple University - Temple Lung Center
Philadelphia, Pennsylvania, United States, 19140
Actively Recruiting
8
University of Pittsburgh Medical Center - UMPC Comprehensive Lung Center
Pittsburgh, Pennsylvania, United States, 15213
Not Yet Recruiting
9
Virginia Commonwealth University Health System
Richmond, Virginia, United States, 23298
Not Yet Recruiting
10
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Not Yet Recruiting
Research Team
J
John Carline
A
Angie McFadden
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here