Trial Testing RejuvenAir as Chronic Bronchitis Treatment Still Enrolling in Europe
Enrollment in a clinical trial evaluating the mechanism of action of RejuvenAir Metered Cryospray, CSA Medical’s investigational approach for the treatment of chronic bronchitis, has already passed the halfway point, the company announced.
However, adults ages 40-79 with chronic bronchitis are still being recruited at the University Medical Center Groningen, in the Netherlands, and at the Royal Brompton Hospital, in London. More information on contacts and locations can be found here.
A subset of chronic obstructive pulmonary disease (COPD), chronic bronchitis is characterized by daily cough and excessive mucus production. Currently, there are no approved treatments for the condition — which has led both U.S. and EU regulatory agencies to grant RejuvenAir Cryospray special development designations.
The ongoing European study is testing the therapy’s mechanism of action.
“We know from the [previous] feasibility study that patients [treated with RejuvenAir Cryospray] achieved meaningful improvements in their cough and overall quality of life,” Pallav Shah, MD, the studies’ principal investigator at the Royal Brompton, said in a press release.
“This study will provide a cellular rationale for the remodeling response observed after metered cryospray and clinical improvements identified in the previous study,” Shah added.
RejuvenAir is a cryosurgical medical device that uses a bronchoscope to reach the lungs and spray a precise dose — or “metered cryospray” — of extremely cold liquid nitrogen onto specific parts of the lungs. The liquid nitrogen is –196°C or –321°F.
The procedure is meant to instantly freeze and destroy the dysfunctional airway cells producing excessive mucus in chronic bronchitis without creating a scar. That then allows the fast regrowth of new, healthy cells, in a process called rejuvenative healing. This minimally invasive procedure is performed under general anesthesia.
The system was named a breakthrough medical device in the U.S. last year — a designation meant to speed up its clinical development and regulatory review. RejuvenAir also was granted the CE Mark in the European Union, meaning it meets EU safety, health, and environmental protection requirements to be marketed.
These decisions were supported by data from the first trial of RejuvenAir Cryospray in chronic bronchitis patients (NCT02483637), which showed that the procedure was generally well tolerated and led to significant and clinically meaningful improvements in patients’ health-related quality of life.
The ongoing mechanism-of-action trial (NCT03892694) is expected to enroll up to 32 adults with chronic bronchitis, who will be randomly assigned to receive either treatment with RejuvenAir Cryospray or a sham procedure.
Eligible patients must have a substantial history of smoking, but not be smoking or using other inhaled tobacco products from two months prior to enrollment and until the end of the trial.
The study aims to identify RejuvenAir Cryospray’s molecular and cellular targets in the central airways of patients, as well as potential associations between the airways’ structural and molecular changes and clinical improvements.
Assessments will be conducted at six months post-intervention, after which those participants assigned to the sham procedure will be allowed to receive treatment with RejuvenAir Cryospray.
“The team is excited to advance our Chronic Bronchitis program and believe that understanding the mechanism to rejuvenative healing in the airways will accelerate the adoption of this first-of-its-kind therapy,” said Wendelin Maners, CSA Medical’s president and CEO.
Another trial, called SPRAY-CB (NCT03893370), is evaluating the safety and effectiveness of RejuvenAir Cryospray against a sham procedure in up to 330 adults, ages 40–80, with moderate to severe COPD and chronic bronchitis.
SPRAY-CB, which dosed its first participant in October 2020, is currently recruiting patients at multiple sites across the U.S. More information on trial locations can be found here.
The main goals of the study are to assess changes in participants’ frequency of exacerbations — when disease symptoms suddenly worsen — and differences in patient-reported quality of life over one year after treatment. Quality of life will be assessed with the St. George’s Respiratory Questionnaire.
“Both this study and the SPRAY-CB pivotal trial in the United States are drawing strong interest from patients and are actively enrolling,” Maners said.
According to CSA Medical, an estimated 9 million of the reported 16 million COPD patients in the U.S. are diagnosed with chronic bronchitis each year. Of these patients, about 700,000 are hospitalized for symptoms or exacerbations of chronic bronchitis annually.
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