RejuvenAir® System Trial for COPD With Chronic Bronchitis

Chronic Obstructive Pulmonary Disease (COPD) is defined as an impaired ability to move air within the lungs and is a major public health problem that is projected to rank fifth worldwide in terms of disease burden and third in terms of mortality. Chronic bronchitis (CB) is a common clinical phenotype within the umbrella of a COPD diagnosis and is classically defined as chronic cough and sputum production for 3 months a year for 2 consecutive years2, but many studies have used different definitions to define it- chronic cough and sputum production for one year or cough and sputum production on most days of the week. CB is associated with multiple clinical consequences, including; the worsening of lung function decline, increasing risk of acute exacerbations of COPD, increased risk of developing pneumonia, reduced health related quality of life, and an increase in all-cause mortality.

NCT Number	NCT03893370
Lead Sponsor	CSA Medical, Inc.
Conditions	Chronic Bronchitis
Enrollment	210 participants
Start Date	2020-07-09
Primary Completion	2025-05 (estimated)
Study Completion	2026-09 (estimated)
Updated on ClinicalTrials.gov	2024-06-03