The objective of this trial is to evaluate the safety and effectiveness of Targeted Lung Denervation (TLD) for COPD patients using the lung denervation radiofrequency ablation device.
Participants aged ≥40 and ≤ 85 years;
Diagnosis of COPD with post-bronchodilator PFT parameters FEV1/FVC<70% and 20% ≤ FEV1 ≤ 60% of predicted; if FEV1<30%pred, PaCO2≤50mmHg;
CAT ≥ 10 or mMRC ≥2;
Non-smoking for a minimum of 2 months prior to consent and agrees to not smoke for the duration of the clinical investigation;
BMI < 18 or > 35;
Asthma as defined by the GINA guideline (2022);
Patient has been previously diagnosed with a non-COPD active lung disease (e.g., active tuberculosis);
Patient has a medical history of pneumothorax within 6 months before the screening visit;
Parallel
TLD
DevicePatients allocated to experimental group will receive TLD therapy during which radiofrequency energy will be delivered to vagus nerve surrounding airway under bronchoscopy.
Sham TLD procedure
Other interventionPatients allocated to control group will receive sham TLD procedure during which catheter will be placed in all treatment locations with no radiofrequency energy delivered.
Standard of care
Other interventionPatients will also receive standard of care that meet the recommendations of GOLD guideline.
Change of Forced expiratory volume in first second (FEV1) relative to baseline
Defined as change in FEV1 at 6 months relative to baseline in the experimental group, compared to the control group.
Time to first moderate or severe COPD exacerbation, first severe COPD exacerbation and first respiratory-related hospitalization.
Defined as a comparison between study arms of the survival distributions for events based on log-rank tests.
Change in St. George's Respiratory Questionnaire COPD Version (SGRQ-C) Total score
Defined as a comparison between study arms of the mean change in SGRQ-C from baseline. The SGRQ-C is a questionnaire developed to measure health status (quality of life) in COPD patients with a total and three component scores for: symptoms, activity and impacts; each score ranges from 0 (no impairment) to 100 (worst possible).
Change in modified Medical Research Council (mMRC) scale Total score
Defined as a comparison between study arms of the mean change in mMRC from baseline. The modified Medical Research Council (mMRC) scale is recommended for conducting assessments of dyspnea and disability and functions. Total score ranging 0 to 4. The higher the score, the more deterioration in severity of dyspnea.
Change in COPD Assessment Test (CAT) Total score
Defined as a comparison between study arms of the mean change in CAT from baseline. The CAT is a disease-specific HRQL with eight questions; each score ranges from 0 (no impairment) to 5 (worst possible). The CAT has a scoring range of 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
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