AIRFLOW-3 (COPD) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn if the study procedure, Targeted Lung Denervation, can help COPD flare-ups and potential hospitalizations.

What is the Condition Being Studied?

COPD

The primary purpose of conducting this study is to evaluate if Targeted Lung Denervation (TLD)Therapy in addition to optimal medical care (daily breathing medications you have been prescribed by your doctor) is better at reducing a moderate or severe worsening of symptoms (known as an COPD flare-ups or exacerbations) and related hospitalizations than optimal medical care alone.

Who Can Participate in the Study?

Men and women ages 40-75 that
- Have not smoked in 2 months
- Have a previous history of smoking
- Diagnosed with COPD
- Have had a flare-up that required medical treatment
- Have not had surgetry on stomach
- Do not have medical device implanted

Age Group
Adults

What is Involved?

If you choose to join this study you will:
-Be randomized (like flipping a coin) to either Group 1 or Group 2
--Group 1 will receive the study procedure, Targeted Lung Denervation (TLD) which is radiofrequency delivered to the nerves in addition to their daily breathing medications
--Group 2 will continue their optimal care and breathing medications
- Get a bronchoscopy
- Complete blood draws
- Get a flu shot once a year
- Do Pulmonary (Lung) Function Tests (PFTs)
- Do 6 minute walking tests
- Get a CT scan done
- Complete questionnaires
- Do follow-up visits over the phone and in person for 5 years

Study Details

Full Title
A Multicenter, Randomized, Sham-controlled Study to Evaluate Safety and Efficacy After Treatment with the Nuvaira? Lung Denervation System in Subjects with Chronic Obstructive Pulmonary Disease (COPD) (AIRFLOW-3)
Principal Investigator
Protocol Number
IRB: PRO00101912
NCT: NCT03639051
Phase
Phase III
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
Participate
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698