This is a prospective, randomized, parallel group, sham-controlled, multicenter clinical trial. The objective is to evaluate the safety and effectiveness of pulsed electric field ablation system manufactured by Suzhou Hengruihongyuan Medical Technology Co., Ltd. for the treatment of the symptoms of chronic bronchitis in adult COPD patients with moderate to severe chronic bronchitis. A total of 210 patients will be randomized into the experimental group and the sham group (2:1).
Subject's age is ≥35 years and ≤80 years.
Patient has chronic bronchitis, defined as productive cough for three months in each of two successive years, whereas other causes of productive cough have been ruled out.
Patient has a CAT score ≥ 10.
Patient has an SGRQ score ≥ 25.
Patient has known unresolved lower respiratory tract infection (e.g., pneumonia, mycobacterium avium-intracellulare infection (MAI), fungus, tuberculosis).
Patient has a steroid-dependent condition requiring >10 mg of oral corticosteroid per day.
Patient has any implantable electronic device (e.g., pacemaker, cardioverter defibrillator) that cannot be turned off during the procedure.
Patient has a history of ventricular tachy-arrhythmia or clinically significant atrial tachyarrhythmia within the past two years, or sinus bradycardia with a heart rate of under than 45 beats per minute, unless the arrhythmia has been treated and/or patient is in regular rhythm during the screening phase.
Parallel
Pulse electric field ablation system
DeviceBronchial rheoplasty (BR) 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.
Sham Procedure
DeviceStaged sham procedure: 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
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.
COPD Assessment Test (CAT) Score (items 1 and 2)
Mean change from baseline in mean total scores for items 1 and 2 of the bilateral CAT scores (ranges from 0 to 10), where lower scores represent lower symptom burden.
St. George Respiratory Questionnaire (SGRQ-C)
Change from baseline in the total score of the COPD of the St. George Respiratory Questionnaire (SGRQ-C), the total score ranges from 0 to 100, where lower scores represent lower symptom burden.
Change from baseline in Modified Medical Research Council dyspnea scale (mMRC) scores
Change from baseline in Modified Medical Research Council dyspnea scale (mMRC) scores, rated on a scale from 0 to 4, where lower grades represent lower symptom burden.
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