Pulsed electric field ablation for chronic bronchitis in COPD

A Clinical Evaluation of the Pulsed Electric Field Ablation System for the Treatment of the Symptoms of Chronic Bronchitis in Adult Patients With COPD

This trial will test whether pulsed electric field ablation can reduce symptoms in adults with moderate to severe chronic bronchitis from COPD.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 210 (estimated)
• Ages: 35 Years to 80 Years
• Sex: All
• Sponsor: Suzhou Hengruihongyuan Medical Technology Co. LTD (industry)
• Drugs / interventions: chemotherapy
• Locations: 13 sites (Hefei, Anui and 12 other locations)
• Trial ID: NCT07068438 on ClinicalTrials.gov

What this trial studies

This is a randomized, parallel-group, sham-controlled multicenter trial that will enroll 210 adults with moderate to severe chronic bronchitis related to COPD and randomize them 2:1 to active pulsed electric field ablation or a sham procedure. The device being tested is a pulsed electric field ablation system manufactured by Suzhou Hengruihongyuan Medical Technology Co., Ltd. Eligible participants must meet symptom thresholds (CAT ≥ 10, SGRQ ≥ 25), airflow obstruction criteria (FEV1/FVC < 0.70 and post-bronchodilator FEV1 ≥ 30% predicted), and be receiving guideline-directed long-acting bronchodilator therapy. The trial will collect safety and effectiveness outcomes focused on symptom relief and quality of life compared to the sham procedure.

Who should consider this trial

Good fit: Adults aged 35–80 with COPD and chronic bronchitis who have persistent symptoms (CAT ≥ 10, SGRQ ≥ 25), airflow obstruction (FEV1/FVC < 0.70 and post-bronchodilator FEV1 ≥ 30% predicted), and are on guideline-directed long-acting bronchodilator therapy are the intended participants.

Not a fit: Patients with other causes of productive cough, very low lung function below the trial threshold (<30% predicted), or who do not meet the symptom criteria are unlikely to receive benefit from this procedure.

Why it matters

Potential benefit: If successful, the procedure could reduce cough and sputum production and improve quality of life for people with chronic bronchitis on top of existing inhaled treatments.

How similar studies have performed: This is a novel application of pulsed electric field ablation for chronic bronchitis with limited prior clinical data in this indication, though pulsed electric field techniques have been explored in other organ systems.

Eligibility criteria

Inclusion Criteria:

1. Subject's age is ≥35 years and ≤80 years.
2. 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.
3. Patient has a CAT score ≥ 10.
4. Patient has an SGRQ score ≥ 25.
5. Patient's responses to the first two questions of the CAT instrument sum to ≥ 7 points or the sum is 6 points and the patient's total CAT score is \> 20 points.
6. Patient has FEV1/FVC \< 0.70.
7. Patient has a pre-procedure post-bronchodilator FEV1 percent predicted of ≥ 30%.
8. Patient is receiving guideline directed pharmacotherapy which includes one or more long acting bronchodilator (LAMA, LABA) with or without an inhaled corticosteroid for at least 8 weeks prior to randomization, unless the patient has attempted such therapy within the past 1 year without significant clinical response or had an adverse reaction.
9. In the opinion of the Primary investigator, patient is able to undergo 2 bronchoscopies under general anesthesia and is able to adhere to the study follow-up schedule.
10. Informed consent signed by the patient or legal representative.

Exclusion Criteria:

1. Patient has known unresolved lower respiratory tract infection (e.g., pneumonia, mycobacterium avium-intracellulare infection (MAI), fungus, tuberculosis).
2. Patient has a steroid-dependent condition requiring \>10 mg of oral corticosteroid per day.
3. Patient has any implantable electronic device (e.g., pacemaker, cardioverter defibrillator) that cannot be turned off during the procedure.
4. 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.
5. Subject has lung cancer.
6. Patient has a pulmonary nodule or cavity that in the judgement of the Primary investigator may require intervention during the course of the study.
7. Patient had prior lung surgery, such as lung transplant, LVRS, lobectomy, lung implant/prosthesis, metal airway stent, valves, coils or bullectomy.
8. Patient has emphysema of greater than or equal to 50% as quantified on baseline HRCT scan as determined by the CT Core Lab.
9. Patient has asthma based on Global Initiative for Asthma (GINA) criteria.
10. Patient has clinically significant bronchiectasis influencing the patient's clinical symptoms of cough and phlegm.
11. Patient has actively smoked (including tobacco, marijuana, e-cigarettes, vaping, etc.) within the last 2 months.
12. Patient is unable to walk over 225 meters in 6 minutes.
13. Patient has a serious medical condition that, in the Primary investigator's opinion, could compromise patient safety or confound the interpretation of the patient's response to therapy (e.g., congestive heart failure, cardiomyopathy, or myocardial infarction in the past year, renal failure, liver disease, cerebrovascular accident within the past 6 months, uncontrolled diabetes (HbA1c \>8%), uncontrolled hypertension (diastolic BP \>100mmHg) or autoimmune disease requiring treatment with immunosuppressant medications or a disease requiring chemotherapy).
14. Patient has uncontrolled GERD.
15. Patient has known severe pulmonary hypertension (pulmonary artery SP ≥ 50 mmHg).
16. Patient has a known sensitivity to medication required to perform bronchoscopy (i.e., lidocaine, atropine, benzodiazepines).
17. Patient is pregnant, nursing, or planning to get pregnant during study duration.
18. Patient is currently participating in another clinical study involving an investigational product.
19. Patient is receiving anticoagulation for a cardiovascular indication and, in the Primary investigator's opinion, unable to suspend anticoagulant medications (i.e., aspirin, clopidogrel, warfarin) during bronchoscopy in accordance.
20. Patient has known airway colonization with drug-resistant bacteria such as Pseudomonas aeruginosa, methicillin-resistant Staphylococcus aureus, Burkholderia cepacia complex, Mycobacterium tuberculosis, Mycobacterium abscessus, Trichoderma, or other significant fungi.

Where this trial is running

Hefei, Anui and 12 other locations

• Anhui Chest Hospital — Hefei, Anui, China (NOT_YET_RECRUITING)
• Affiliated Beijing Chaoyang Hospital of Capital Medical University — Beijing, Beijing Municipality, China (NOT_YET_RECRUITING)
• Hospital Emergency General — Beijing, Beijing Municipality, China (NOT_YET_RECRUITING)
• The First People's Hospital of Changzhou — Changzhou, Jiangsu, China (NOT_YET_RECRUITING)
• The Second Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (NOT_YET_RECRUITING)
• The Second People's Hospital of Wuxi — Wuxi, Jiangsu, China (NOT_YET_RECRUITING)
• The Affiliated Hospital of Xuzhou Medical College — Xuzhou, Jiangsu, China (NOT_YET_RECRUITING)
• The First Affiliated Hospital Of Nanchang University — Nanchang, Jiangxi, China (NOT_YET_RECRUITING)
• Sir Run Run Shaw Hospital, affiliated with Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (RECRUITING)
• Jinhua Central Hospital — Jinhua, Zhejiang, China (NOT_YET_RECRUITING)
• Lishui Central Hospital — Lishui, Zhejiang, China (NOT_YET_RECRUITING)
• Quzhou People's Hospital — Quzhou, Zhejiang, China (NOT_YET_RECRUITING)
• Shaoxing People's Hospital — Shaoxing, Zhejiang, China (NOT_YET_RECRUITING)

Study contacts

• Study coordinator: Enguo Chen

Conditions: Chronic Bronchitis, COPD