Trial testing RejuvenAir device in chronic bronchitis is fully enrolled
If positive, study data may support approval application in US for COPD
Enrollment is now complete in a clinical trial testing RejuvenAir, CSA Medical’s minimally invasive device, in adults with chronic bronchitis — one of the most common forms of chronic obstructive pulmonary disease (COPD).
The trial, called SPRAY-CB (NCT03893370), enrolled 210 patients at sites across the U.S. and one in the U.K. nearly two months ahead of schedule. If positive, its data may support an application for approval of RejuvenAir in the U.S., where it has been designated a breakthrough device as an incentive to speed its development.
The device already is cleared for use in Europe for treating COPD with chronic bronchitis.
“We enrolled almost 25% of the study in the last four months reflecting the strong interest in a device therapy that goes beyond pharmaceutical management of the disease,” Heather Nigro, CSA’s senior vice president of clinical and regulatory affairs, said in a company press release.
For Wendelin Maners, CEO of CSA, completing SPRAY-CB’s enrollment “is a critical achievement for CSA Medical as we strive to bring a new, first-of-its-kind medical device therapy to the millions of COPD patients struggling with the debilitating symptoms of chronic bronchitis.”
“We want to thank the clinical trial participants, investigators, and sites whose significant interest in this breakthrough device therapy drove strong recruitment,” Maners added.
RejuvenAir uses extremely cold liquid nitrogen to destroy damaged cells
COPD covers a range of lung diseases, including chronic bronchitis, which is characterized by chronic lung inflammation and increased mucus production, as well as cough with productive mucus, or sputum, for two consecutive years.
RejuvenAir sprays small, metered doses of extremely cold liquid nitrogen that rapidly freeze the lining of the airways. Damaged cells are destroyed, making room for new healthy cells. These include mucus-producing goblet cells and ciliated epithelial cells that sweep debris away from the lungs.
The treatment is delivered with the help of a bronchoscope, a thin, flexible tube that’s passed through the nose or mouth, down the throat, and into the patient’s lungs.
An earlier clinical trial (NCT02483637) had tested the device’s use against a sham (control) procedure in 19 men and 16 women with COPD, ages 47 to 76. Treatment with RejuvenAir was well tolerated and resulted in reduced symptoms and quality of life improvements after three months compared with the control procedure.
Now, SPRAY-CB is evaluating RejuvenAir’s one-year safety and efficacy against a sham procedure in 210 adults, ages 40 to 80, with moderate to severe COPD and chronic bronchitis.
The main goal is to watch for changes in St. George Respiratory Questionnaire scores. This questionnaire measures the impact of COPD on overall health, daily life, and perceived well-being, with higher scores indicating more limitations.
Secondary goals include safety measures, as well as changes in cough, sputum, and acute exacerbations, or a sudden worsening of symptoms.
The company also is running a clinical trial (NCT03892694) in the Netherlands and the U.K. investigating in greater depth the mechanisms of action of RejuvenAir in 32 adults, ages 40 to 79, with chronic bronchitis. The main goal of this study, which is fully enrolled, is to watch for changes in the number of goblet cells, with secondary goals including changes in other lung cells and patient-reported outcome measures.
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