SPRAY-CB : RejuvenAir® System Trial for COPD With Chronic Bronchitis
Status: Active, not recruiting.
The RejuvenAir® System is a cryosurgical device that applies medical-grade liquid nitrogen to the treatment area to ablate tissue in the airways that causes cough and sputum production and allow regrowth of healthier epithelial cells to reduce the symptoms associated with chronic bronchitis. This is study designed to demonstrate the safety and effectiveness of the RejuvenAir® System for the treatment of adults with a diagnosis of chronic bronchitis and COPD comparing treatment to Sham Control Arm in a 2:1 randomised control trial. Those randomized to the Sham Control Arm will have the option to cross over to the treatment arm after the 12 month follow up visit. Patients in this study will be followed for 24 months.