Following a stop due to the COVID-19 pandemic, the Medical University of South Carolina (MUSC) has become the first medical center to restart the AIRFLOW-3 clinical trial, which is testing a procedure called targeted lung denervation as a potential therapy for chronic obstructive pulmonary disease (COPD).
“We’re thoughtfully re-engaging in a safe program,” Charlie Strange, MD, professor of pulmonary and critical care medicine at MUSC, said in an university news story.
Targeted lung denervation involves putting a specialized catheter in the lungs, and then using radio waves to destroy nerves thought to regulate airway constriction and mucus production. By disrupting nerve transmission, targeted lung denervation is intended to cause airways to relax and decrease mucus production. That, in turn, is expected to reduce COPD exacerbations.
Conceptually, this is similar to how bronchodilators — medications for COPD that literally mean “airway wideners” — work. Importantly, targeted nerve denervation is not meant to be a replacement for these medications; instead, it is intended to make them more effective.
“With one hour’s worth of work, we can open up your airways and make them responsive to the medicines we give as bronchodilators,” Strange said. “We do see higher lung function, but the real goal is to turn on a therapy that will stop exacerbations from happening and really improve global quality of life over the years.”
The primary cause of exacerbations is thought to be mucus, Strange said. A patient’s symptoms become markedly worse during an exacerbation, which can even lead an individual to develop new symptoms.
“Exacerbations are what take people to emergency rooms and hospitals,” he said. “And exacerbations of COPD cost $50 billion a year in the United States.”
The primary goal of the ongoing AIRFLOW-3 clinical trial (NCT03639051) is to test whether targeted lung denervation can reduce the frequency of COPD exacerbations over the course of one year. In addition to exacerbations, the patients’ quality of life, lung function, and hospitalization rates also will be assessed.
AIRFLOW-3 is being sponsored by Nuvaira, a company that makes a medical device for targeted lung denervation.
The trial is expected to enroll about 520 participants, ages 40 to 78, at locations in Austria, the United States, France, Germany, the United Kingdom, and the Netherlands. Enrollment is ongoing; additional information can be found here.
Participants in the trial will be randomly selected to receive an active or sham treatment. In the sham treatment, no radio waves are used and thus no nerves are killed.
The first trial participant to undergo the procedure at MUSC in the COVID-19 era is Les Hall, a resident of Aiken, S.C., who has lived with COPD since the early 2000s.
“The staff [at MUSC] was wonderful,” Hall said.
“Everybody that was there to help and to do something with or for me came by and introduced themselves before the procedure and told me what they were going to do,” he said. “I was very impressed by that. Everybody’s busy, and they’ve got things to do, but they took time to make this personal.”
An avid golfer, Hall said the effects of COPD had led him to curtail his time out on the course in 2019. He went from playing golf three or four times per week to only playing about 20 times all year. He hopes this treatment will prevent exacerbations.
“I’m hoping to see a slight improvement,” Hall said. “I’m not looking to become a long-distance swimmer or anything like that. If I get a little improvement in my breathing capacity, that’s wonderful. If this keeps me plateaued at this level for a longer period of time, that’s great.”