RejuvenAir System Tested in 1st Trial Participant With COPD and Chronic Bronchitis
The first participant has been treated in a clinical trial testing CSA Medical’s RejuvenAir System as a potential treatment for people with moderate to severe chronic obstructive pulmonary disease (COPD) with chronic bronchitis.
The participant was treated at Temple University Hospital. At present, the multicenter international trial, called SPRAY-CB (NCT03893370), is actively recruiting participants at multiple locations in the U.S. Further details on trial locations are available here.
“This clinical trial offers patients who suffer from COPD with chronic bronchitis a procedural option that has the potential to address more than just symptoms,” Gerard J. Criner, MD, professor at Temple University and the overall principal investigator for the trial, said in a press release.
“We are pleased here at the Temple Lung Center to be able to expand the treatment and clinical trial options for our patients with this long-term, progressive disease,” added Criner, who is the center’s director.
Chronic bronchitis is a type of COPD characterized by inflammation and irritation of the bronchial airways, leading to a productive cough that can persist for months or years. According to CSA Medical, of the approximately 16 million people with COPD in the U.S., an estimated nine million have also been diagnosed with chronic bronchitis. Currently, there are no approved therapies for this condition.
The RejuvenAir System uses a bronchoscope to reach the lungs and spray extremely cold liquid nitrogen, as cold as –196°C (or –321°F), onto specific parts of the lungs. This is intended to destroy mucus-producing cells, allowing healthy cells to grow in their place. The procedure is performed under general anesthesia.
The system was designated a breakthrough medical device by the U.S. Food and Drug Administration in 2019, and received the CE mark in Europe the same year.
SPRAY-CB, which is sponsored by CSA Medical, aims to enroll approximately 330 people who have been diagnosed with COPD and chronic bronchitis for at least two years.
To be eligible, participants must be 40 to 80 years old. Participants must also have a substantial history of smoking, but must not be smoking or using other inhaled tobacco products during the trial.
Participants in the trial will be treated with the RejuvenAir System or a sham procedure.
The trial’s main efficacy measurements are the frequency of exacerbations (when disease symptoms suddenly worsen) and participants’ quality of life, as assessed with the St. George’s Respiratory Questionnaire (a patient-reported measurement), 12 months post-treatment.
“COPD exacerbations and symptoms greatly impact patients’ quality of life,” Criner said. “At the Temple Lung Center, we are committed to research that addresses this, as quality of life is one of our patients’ chief concerns.”
Additional information about the trial can be found here.