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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
200
Patients allocated to experimental group will receive TLD therapy during which radiofrequency energy will be delivered to vagus nerve surrounding airway under bronchoscopy.
Patients allocated to control group will receive sham TLD procedure during which catheter will be placed in all treatment locations with no radiofrequency energy delivered.
Patients will also receive standard of care that meet the recommendations of GOLD guideline.
West China Hospital of Sichuan University
Chengdu, Sichuan, China
RECRUITINGChange 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 frame: 6 Months
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.
Time frame: 12 Months
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).
Time frame: 6 and 12 Months
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.
Time frame: 6 and 12 Months
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.
Time frame: 6 and 12 Months
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Change in Pulmonary Function
Defined as a comparison between study arms of the mean change in FEV1%pred, FVC(%pred), RV(%pred) from baseline.
Time frame: 6 and 12 Months
Change in 6-minute walk distance (6MWD)
Defined as a comparison between study arms of the mean change in 6MWD from baseline.
Time frame: 6 and 12 Months
Device Success Rate of experimental group
Defined as the proportion of the number of ablation procedures in which the catheter would be successfully placed on the treatment site and the catheter would be successfully withdrawn after the completion of the treatment procedure in all the ablation procedures.
Time frame: Immediately after the procedure
(Serious) Adverse Event Rate related to device or procedure
Defined as the total number of events per total number of treatment years.
Time frame: Through study completion, an average of 1 year