AIRFLOW-3 - 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.
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
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