Enrollment Complete for RejuvenAir Metered Cryospray Trial
Enrollment is now concluded in a clinical trial evaluating the mechanism of action of RejuvenAir Metered Cryospray, an investigational treatment for chronic bronchitis, the most common form of chronic obstructive pulmonary disease (COPD).
Chronic bronchitis is long-term inflammation of the airways, characterized by coughing and excessive mucus production. RejuvenAir Metered Cryospray is a medical device that uses a bronchoscope — a thin tube passed through the nose or mouth, down the throat, and into the patient’s lungs — to spray a precise dose of extremely cold liquid nitrogen onto certain parts of the lungs. This is meant to destroy impaired cells that produce excessive amounts of mucus, allowing for the fast regrowth of healthier cells.
The minimally invasive procedure is performed under general anesthesia.
The goal of the now fully enrolled trial (NCT03892694), which had started recruiting participants last year, is to determine how precise sprays of freezing liquid nitrogen — also called metered cryospray or MCS — reduces the density of mucus-producing cells, called goblet cells. Researchers also intend to look for molecular and cellular evidence of healthy cell growth.
Participants will be randomly selected to undergo MCS with the RejuvenAir system, or have a sham procedure. Assessments will be done six months after the intervention, at which point participants given the sham procedure will have the option to receive the active treatment.
RejuvenAir has been granted the CE Mark in the European Union and named a breakthrough medical device in the U.S. The CE Mark is required for many products before they can be sold in the EU. The breakthrough medical device designation is intended to speed the device’s clinical development in the U.S. Such status is granted to devices that offer therapeutic advantage over existing technologies.
Those actions were based on data from an earlier trial (NCT02483637) of RejuvenAir Cryospray in people with chronic bronchitis. Data from that study showed the procedure was generally well-tolerated and led to significant and clinically meaningful improvements in participants’ health-related quality of life.
“In the previous study, we saw meaningful improvements in patient symptoms and quality of life,” Pallav Shah, MD, from the Royal Brompton in London, said in a press release.
“What makes this study different is that we will now be able to provide the cellular rationale for the remodeling response we observed in the feasibility study after treatment with RejuvenAir. In other words, we will prove re-epithelialization [a part of wound healing] and regrowth of healthy airway tissue,” Shah said.
In addition to the mechanism of action study, CSA Medical, the company developing the device, also is sponsoring another study, called SPRAY-CB (NCT03893370). That study will test the safety and effectiveness of RejuvenAir Cryospray against a sham procedure in up to 330 adults, ages 40–80, who have moderate to severe COPD and chronic bronchitis.
“Together with the final data from the SPRAY-CB pivotal study, we endeavor to understand not only that metered cryospray reduces the symptoms of chronic bronchitis, but also answer how it works to rejuvenate airways for a better quality of life,” said Heather V. Nigro, senior vice president of regulatory, quality and clinical affairs at CSA Medical.
“We anticipate the RejuvenAir System will be the first minimally invasive treatment option for this population,” Nigro said, noting that “current medications only manage [the] symptoms.”