Efficacy and Safety of Broncho Muco Cleaner Balloon Dilation Therapy (EXERTION)
COPD
About this trial
This is an interventional prevention trial for COPD focused on measuring Chronic Bronchitis, Medical Device, Baloon Dilatation
Eligibility Criteria
Inclusion Criteria: Adults of both sexes aged 40-75 years Being diagnosed with stage II-IV chronic bronchitis-predominant COPD according to the GOLD guideline To have quit smoking for at least 6 months mMRC 2 and above Receiving optimal medical treatment for COPD Being stable for at least 3 weeks To have completed 6 weeks of pulmonary rehabilitation before the first procedure Having sufficient mental and physical capacity to sign the voluntary consent form for the procedure. Exclusion Criteria: be under the age of 40 and over the age of 75 pregnant patients breastfeeding a child Being an active smoker Concurrent asthma Chronic kidney disease with GFR <30 ml/min Clinically significant arrhythmia, Left heart failure (EF<45) or pulmonary hypertension (PABs>45 mmHg) Liver cirrhosis Those who use anticoagulants or clopidogrel or equivalent drugs and cannot be stopped before and during the procedure, or the presence of bleeding diathesis 6 minutes walking test <100 meters FEV1<15% Those with positive early reversibility in pulmonary function tests Patients who do not regularly take 15lgu15in therapy for COPD Emphysema-predominant COPD patients Presence of active malignancy Partial CO2 pressure > 55mmHg or pO2<55 mmHg in room air Active pulmonary infection Pneumothorax or pulmonary surgery in the last 6 months Patients with other clinically significant lung disease other than COPD Those who have undergone a previous lung device procedure, including implanted emphysema stents, lung coil delivery, valves, lung denervation, or other devices for emphysema. Those taking > 10 mg of prednisolone per day Those with a known sensitivity to the drug (such as lidocaine, 15lgu15ine and benzodiazepines) needed to perform bronchoscopy.
Sites / Locations
- Istanbul Yedikule Chest Diseases and Thoracic Surgery Training and Research HospitalRecruiting
Arms of the Study
Arm 1
Experimental
Broncho Muco Cleaner
It will be applied to patients with a diagnosis of chronic bronchitis-predominant COPD, who cannot achieve adequate clinical and functional improvement despite optimal medical therapy. In patients who meet the patient selection criteria, anesthesia approval will be obtained before the procedure will be performed under general anesthesia