COPD
Conditions
Interventions
experimental group:Targeted lung denervation + Standard of Care
control group:Sham-control + Standard of Care
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Participants aged =40 and = 75 years; 2.Diagnosis of COPD with post-bronchodilator PFT parameters FEV1/FVC) for =12 months at the time of consent; 7.Received an influenza vaccine within the 12 months prior to consent or agrees to obtain an influenza vaccine during the clinical investigation, and agrees to annual influenza vaccines for the duration of the clinical investigation; 8.Resting SpO2 = 89% at the time of screening; 9.Willing, able, and agrees to complete all protocol required baseline and follow-up testing assessments including finishing the Patient Diary; 10.Able to understand the purpose of the clinical investigation, agree to participate in the trial and able to complete the informed consent signature.
Exclusion criteria
Exclusion criteria: 1.BMI 35; 2.Asthma as defined by the GINA guideline (2022); 3.Patient has been previously diagnosed with a non-COPD active lung disease (e.g., active tuberculosis); 4.Patient has a medical history of pneumothorax; 5.Known contraindication or allergy to medications required for bronchoscopy or general anesthesia that cannot be medically controlled; 6.Recent respiratory infections or COPD exacerbation in preceding 4 weeks; 7.Malignancy treated with radiation or chemotherapy within 2 years of consent; 8.Daily use of > 10 mg of prednisone or its equivalent at the time of consent; 9.Recent (within 3 months of consent) opioid use; 10.Known gastrointestinal motility disorder or previous abdominal surgical procedure on stomach, esophagus, or pancreas 11.Has an implantable electronic device; 12.Previous or planned pulmonary or thoracic surgery (including but not limited to: pneumonectomy, lung transplantation, pulmonary medical device intervention ) during this trial; 13.Myocardial infarction within last 6 months, EKG with evidence of life-threatening arrhythmias or acute ischemia, pre-existing documented evidence of a LVEF 50 mmHg; 15.Pulmonary nodule or other lesions thought to be at high risk of malignancy; 16.Clinically relevant bronchiectasis, defined as severe single lobe or multilobar bronchial wall thickening associated with airway dilation on CT scan leading to cough, intractable expectoration and repeated hemoptysis lasting for several days; 17.In the opinion of the Investigator, use of the TLD devices is not feasible, for example, due to screening chest CT scan reveals severe emphysema or bronchi anatomy cannot be fully treated with available catheter sizes: severe bullous disease (> 1/3 hemithorax) or site discovery of a mass that requires treatment; 18.A GCSI total symptom score = 18.0 prior to treatment; 19.Any disease or condition that might interfere with completion of a procedure or this study (e.g., life expectancy< 1 years); 20.Women of childbearing potential must have a negative pregnancy test (blood or urine) pre-treatment and agree not to become pregnant for the duration of the study 21.Participated in any clinical trial and received experimental treatment within 3 months before the screening visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of Forced expiratory volume in first second (FEV1) relative to baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to first moderate or severe COPD exacerbation, first severe COPD exacerbation and first respiratory-related hospitalization;Change in St. George's Respiratory Questionnaire COPD Version (SGRQ-C) Total score;Change in Transition Dyspnea Index (TDI);Change in modified Medical Research Council (mMRC) scale Total score;Change in COPD Assessment Test (CAT) Total score;Change in Pulmonary Function (FEV1%pred?FVC?RV);Change in 6-minute walk distance (6MWD);Device Success Rate of experimental group;(Serious) Adverse Event Rate related to device or procedure; | — |
Countries
China
Contacts
Public ContactLuo Fengming
West China Hospital of Sichuan University
Outcome results
None listed