NCT03893370

RejuvenAir® System Trial for COPD With Chronic Bronchitis

A Sham Controlled Prospective Randomized Clinical Trial of the RejuvenAir® System for the Treatment of Moderate to Severe Chronic Obstructive Pulmonary Disease With Chronic Bronchitis

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 210 (actual)
• Sponsor: CSA Medical, Inc. · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The RejuvenAir® System is a cryosurgical device that applies medical-grade liquid nitrogen to the treatment area via a radial head catheter in a small, accurately directed spray. Cryotherapy with the RejuvenAir® System is designed to induce a regenerative endobronchial tissue effect by: 1) destroying via cryotherapy the abnormal surface epithelium that has become overgrown with mucin producing goblet cells, 2) thus allowing normal bronchial epithelium with a regrowth of ciliated epithelial cells that will facilitate the removal of mucins from the bronchial airways and 3) lead to a reduction in chronic inflammation and its accompanying mucosal swelling with resultant increase in the treated airway diameter. This reversal of inflamed epithelium may also lessen systemic inflammation.

Conditions

• Chronic Bronchitis

Interventions

Type	Name	Description
DEVICE	RejuvenAir System	RejuvenAir Metered CryoSpray
DEVICE	Sham Control Procedure	Sham Control Procedure

Timeline

• Start date: 2020-07-09
• Primary completion: 2025-05-01
• Completion: 2026-09-01
• First posted: 2019-03-28
• Last updated: 2024-06-03

Locations

27 sites across 2 countries: United States, United Kingdom

Regulatory

• FDA-regulated device study