Efficacy and Safety of Broncho Muco Cleaner Balloon Dilation Therapy (EXERTION)

Clinodevice

Status: Completed

Conditions: COPD

Treatments: Device: Broncho Muco Cleaner

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05868941

K-BB001-EXERTION

Details and patient eligibility

About

In COPD patients with chronic bronchitis, it is aimed to determine whether the broncho muco cleaner balloon dilation method can provide clinical and functional benefit by causing destruction in hyperplasic goblet cells in the bronchial system. Although 2 studies have been published on this subject before, one of them is a retrospective design and the other is a pilot study consisting of only 10 patients . Therefore, it is clear that it should be supported by a controlled prospective study with more patients.

Within the scope of the research, broncho muco cleaner balloon dilatation treatment will be performed with fiberoptic bronchoscope under general anesthesia in chronic bronchitis-predominant COPD cases, and the effectiveness and reliability of the procedure will be evaluated.

Enrollment: 35 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Broncho Muco Cleaner

Experimental group

Description:

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

Treatment:

Device: Broncho Muco Cleaner