This is a prospective, randomized, parallel group, double-blind, sham-controlled, multicenter clinical trial following patients to 2 years. The objective is to assess the safety and effectiveness of Bronchial Rheoplasty for the treatment of the symptoms of chronic bronchitis in adult COPD patients with moderate to severe chronic bronchitis. A total of 270 patients will be randomized at up to 40 study centers in the United States, Canada, and Europe.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
270
bronchial rheoplasty is a staged procedure wherein pulsed electric fields are delivered to the right lung in the first treatment visit, and then the left lung is treated approximately 1 month later.
staged sham procedure wherein bronchoscopy is performed, the catheter is inserted into the right lung, but energy is not delivered; then the same steps are performed in the left lung approximately 1 month later (no energy is delivered to the patient)
COPD Assessment Test (CAT) Score
Mean change from baseline in the COPD Assessment Test (CAT) total score, the total CAT score ranges from 0 to 40, where lower scores represent lower symptom burden
Time frame: 6 months
Distal Airway Volume
Change from baseline distal airway volume (DAV) at expiration using HRCT scans
Time frame: 6 months
COPD Exacerbations
Rate of moderate and severe COPD exacerbations
Time frame: 12 months
Goblet Cell Hyperplasia
change from baseline in mean goblet cell hyperplasia score as determined from airway biopsy samples; the grading scale ranges from 0 to 3, where lower scores represent less goblet cell hyperplasia
Time frame: 1 month
Cough Frequency
change from baseline in cough frequency (coughs/hour in a 24-hour recording period)
Time frame: 6 and 12 months
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Norton Thoracic
Phoenix, Arizona, United States
Honor Health
Scottsdale, Arizona, United States
Syed M. Alam, MD Pulmonology (Bakersfield Heart)
Bakersfield, California, United States
UC Davis Medical Center
Davis, California, United States
Scripps Health
Encinitas, California, United States
University of Southern California
Los Angeles, California, United States
UCLA Harbor Lundquist Institute
Torrance, California, United States
University of Colorado
Aurora, Colorado, United States
Mayo Clinic
Jacksonville, Florida, United States
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