Lung Denervation for COPD
(AIRFLOW-4 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if a new one-time treatment, called Targeted Lung Denervation (TLD), can help people with Chronic Obstructive Pulmonary Disease (COPD) breathe easier while continuing their regular medication. Researchers seek to confirm the safety and effectiveness of this treatment for those receiving standard COPD care. Suitable candidates for this trial include individuals with moderate to severe COPD who have not smoked in the last two months and experience regular breathing difficulties. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance COPD treatment options.
What prior data suggests that the dNerva Lung Denervation System is safe for COPD patients?
Research has shown that Targeted Lung Denervation (TLD) is safe for people with COPD. In past studies, patients who underwent TLD experienced no serious side effects from the treatment, even up to three years later. The likelihood of severe COPD flare-ups requiring hospital care was also lower in the TLD group compared to those who did not receive the treatment. These findings suggest that TLD is generally well-tolerated and safe for COPD patients.12345
Why are researchers excited about this trial?
Researchers are excited about Targeted Lung Denervation (TLD) for COPD because it offers a novel, minimally invasive approach to treatment. Unlike standard medications like LABA/ICS, LAMA/LABA, or LABA/LAMA/ICS, which manage symptoms through inhalers and pills, TLD directly targets the nerves in the lungs to reduce nerve signaling, potentially improving lung function and reducing symptoms. This one-time bronchoscopic procedure could provide longer-lasting relief without the need for daily medication adjustments, which is why it’s capturing the attention of the medical community.
What evidence suggests that the dNerva Lung Denervation System is effective for COPD?
Research has shown that Targeted Lung Denervation (TLD) could benefit people with COPD (Chronic Obstructive Pulmonary Disease). In this trial, some participants will receive TLD treatment in addition to their standard COPD medical care. One study found that patients who received TLD experienced fewer sudden flare-ups of symptoms over a year. This treatment also eased breathing and slowed the decline in lung function. TLD interrupts nerve signals that can cause airways to tighten, making breathing easier. Overall, evidence suggests that TLD can effectively manage COPD symptoms.25678
Who Is on the Research Team?
Prof. Gerard Criner, MD
Principal Investigator
Temple Health
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a one-time bronchoscopically guided minimally invasive treatment using the dNerva Lung Denervation System
Follow-up
Participants are monitored for safety and effectiveness after treatment
Crossover Treatment
Participants in the 'No Intervention' arm have the option to receive TLD treatment after completing 1-year follow-up
What Are the Treatments Tested in This Trial?
Interventions
- Targeted Lung Denervation (TLD)
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
Participants in 'No Intervention' arm who complete their 1-year follow-up will have the option to receive TLD treatment and will be followed for 1 year after the crossover treatment.
Targeted Lung Denervation (TLD)Therapy is a bronchoscopically guided minimally invasive one-time treatment using the dNerva Lung Denervation System. Patients will also continue taking their standard of care COPD maintenance medication (at minimum LABA/ICS, LAMA/LABA or LABA/LAMA/ICS) that they were on prior to randomization.
Continue taking their same standard of care COPD maintenance medication (at minimum LABA/ICS, LAMA/LABA or LABA/LAMA/ICS) that they were on prior to randomization.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Nuvaira, Inc.
Lead Sponsor
Honor Health - Clinical Trials
Collaborator
University of Pittsburgh Medical Center
Collaborator
Royal Brompton & Harefield NHS Foundation Trust
Collaborator
Ohio State University
Collaborator
University of Alabama at Birmingham
Collaborator
Temple Health
Collaborator
Medical College of Wisconsin
Collaborator
Citations
Targeted Lung Denervation in Chronic Obstructive Pulmonary ...
Targeted tissue ablation along the main bronchi using a radiofrequency catheter blocks parasympathetic signaling within bronchial nerve branches, decreasing ...
Study Details | NCT07051707 | Evaluating the Safety and ...
The purpose of this study is to confirm the safety and efficacy of the Nuvaira Lung Denervation System in the treatment of COPD.
Randomized Sham-controlled Trial of Targeted Lung ... - PMC
AIRFLOW-3 was a 1:1 randomized, double-blind, sham-controlled trial of the D'Nerva targeted lung denervation (TLD) system in patients with chronic obstructive ...
Targeted Lung Denervation for COPD at 12 Months
Patient with chronic obstructive pulmonary disease (COPD) continued to derive benefit from targeted lung denervation (TLD), experiencing fewer acute ...
AIRFLOW-3 Data for Targeted Lung Denervation in COPD, ...
Additionally, results showed the treatment arm exhibited a statistically significant improvement in dyspnea at 1 year compared to sham, leading ...
Safety of denervation following targeted lung ... - PMC
TLD in COPD patients demonstrated a positive safety profile out to 3 years, with no late-onset serious adverse events related to denervation therapy.
Safety and Adverse Events after Targeted Lung Denervation ...
The risk of severe COPD exacerbation requiring hospitalization was significantly lower in the TLD treatment group than in the sham patient group at 12.5 months ...
Targeted Lung Denervation in Chronic Obstructive Pulmonary ...
Targeted Lung Denervation in Chronic Obstructive Pulmonary Disease: Threading the Needle of Safe Interventions to Help the Sickest Open Access.
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