Clinical trial NCT05868941: Efficacy and Safety of Broncho Muco Cleaner Balloon Dilation Therapy
Official title: Efficacy and Safety of Broncho Muco Cleaner Balloon Dilation Therapy in Chronic Bronchitis-predominant COPD Cases
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: COPD
Keywords: Chronic Bronchitis
Medical Device
Baloon Dilatation
Lead sponsor: Clinodevice
Sponsor class: INDUSTRY
Collaborators: name: Klinar CRO
First posted: 2023-05-22
Enrollment: 35
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study is a multicenter, prospective local medical device clinical trial.
Primary purpose: PREVENTION

Brief summary: 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.


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.

Primary outcomes:
measure: Reliability of the procedure - Safety
timeFrame: 52 weeks
measure: Patients' Tolerence - mMRC dyspnea scale
timeFrame: 52 Weeks
measure: Patients' Tolerence - COPD Exacerbation Number (severity of exacerbation will be indicated as mild, moderate, severe.)
timeFrame: 52 Weeks
measure: Patients' Tolerence - St George Respiratory Questionnaire
timeFrame: 52 Weeks
measure: Patients' Tolerence - 6 min walking test
timeFrame: 52 Weeks
measure: Patients' Tolerence - Pulmonary Function Test (FEV1, FVC values in (lt) and (%) values as well as FEV1/ FVC rate (in %)
timeFrame: 52 Weeks
measure: Detection of Execerbations
timeFrame: 52 weeks
measure: Quality of Life for the device
timeFrame: 52 Weeks
Secondary outcomes:
measure: Improvement in functional parameters - 6 Minute Walk Test (V1-V6)
timeFrame: 52 weeks
measure: Improvement in functional parameters - Pulmonary Function Test (V1-V2-V3-V4-V5-V6)
timeFrame: 52 weeks
measure: Adverse events
timeFrame: 52 weeks
measure: Changes in laboratory test results
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital
Study officials:
affiliation: stanbul Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital
name: Erdogan Cetinkaya
role: PRINCIPAL_INVESTIGATOR
References: