Efficacy and Safety of Broncho Muco Cleaner Balloon Dilation Therapy

COPD Clinical Trial

— EXERTION  

Official title:

Efficacy and Safety of Broncho Muco Cleaner Balloon Dilation Therapy in Chronic Bronchitis-predominant COPD Cases

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05868941
• Other study ID #: K-BB001-EXERTION
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 2, 2022
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: Clinodevice
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 35
• Est. completion date: December 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bronchitis
• COPD

Intervention

Device:
• Broncho Muco Cleaner
The endotracheal tube will be passed with a bronchoscope. During the procedure, the product is connected to the oxygen jack in the hospital, inflated and deflated, turning the thickened goblet cell layer that causes sputum production to foamy liquid. For the procedure, it will be entered through the intubation tube with a fiberoptic bronchoscope, and the airways with a diameter of 3 to 8 mm, primarily the airways, and all the respiratory tract mucosa that can be reached will be treated with a balloon in a total of 3 sessions. For these procedures, balloons selected in accordance with the diameter of the bronchi will be used in the respiratory tract. In patients who meet the patient selection criteria, intervention will be made with a balloon that inflates and deflates at the determined frequency and pressure from the subsegment level that can be reached with the bronchoscope to the inner surface of the airways proximally.

Locations

Country	Name	City	State
Turkey	Istanbul Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Clinodevice	Klinar CRO

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reliability of the procedure - Safety	Reliability of the procedure (adverse events occurring) for 52 weeks post-procedure.	52 weeks
Primary	Patients' Tolerence - mMRC dyspnea scale	Within the scope of the KBB001 Exertion Study, the broncho muco cleaner procedure to be applied to the patients will be performed with fiberoptic bronchoscopy under general anesthesia. Any undesirable event that may be associated with and after the transaction will be recorded. Primary evaluation criteria in determining the Processing efficiency of your device.	52 Weeks
Primary	Patients' Tolerence - COPD Exacerbation Number (severity of exacerbation will be indicated as mild, moderate, severe.)	Within the scope of the KBB001 Exertion Study, the broncho muco cleaner procedure to be applied to the patients will be performed with fiberoptic bronchoscopy under general anesthesia. Any undesirable event that may be associated with and after the transaction will be recorded. primary evaluation criteria in determining the Processing efficiency of your device	52 Weeks
Primary	Patients' Tolerence - St George Respiratory Questionnaire	Within the scope of the KBB001 Exertion Study, the broncho muco cleaner procedure to be applied to the patients will be performed with fiberoptic bronchoscopy under general anesthesia. Any undesirable event that may be associated with and after the transaction will be recorded. primary evaluation criteria in determining the Processing efficiency of your device.	52 Weeks
Primary	Patients' Tolerence - 6 min walking test	Within the scope of the KBB001 Exertion Study, the broncho muco cleaner procedure to be applied to the patients will be performed with fiberoptic bronchoscopy under general anesthesia. Any undesirable event that may be associated with and after the transaction will be recorded. primary evaluation criteria in determining the Processing efficiency of your device.	52 Weeks
Primary	Patients' Tolerence - Pulmonary Function Test (FEV1, FVC values in (lt) and (%) values as well as FEV1/ FVC rate (in %)	Within the scope of the KBB001 Exertion Study, the broncho muco cleaner procedure to be applied to the patients will be performed with fiberoptic bronchoscopy under general anesthesia. Any undesirable event that may be associated with and after the transaction will be recorded. primary evaluation criteria in determining the Processing efficiency of your device.	52 Weeks
Primary	Detection of Execerbations	COPD Exacerbation (COPD Exacerbation) is one of the most important problems of COPD patients and includes the risk of mortality and mirdit. It is expected that the number of exacerbations of the patients will decrease with the broncho muco cleaner balloon treatment. The number and severity of exacerbations (mild, moderate, severe) at each visit of the patient will be noted to assess the effect of treatment on exacerbations.	52 weeks
Primary	Quality of Life for the device	A St George quality of life survey will be conducted and recorded. Every 4-point change in the SGRQ questionnaire will be considered minimal clinical significance.	52 Weeks
Secondary	Improvement in functional parameters - 6 Minute Walk Test (V1-V6)	- 6 Minute Walk Test (V1-V6)	52 weeks
Secondary	Improvement in functional parameters - Pulmonary Function Test (V1-V2-V3-V4-V5-V6)	- Pulmonary Function Test (V1-V2-V3-V4-V5-V6)	52 weeks
Secondary	Adverse events	Adverse events seen (AE)	52 weeks
Secondary	Changes in laboratory test results	Change in blood chemistry tests and hemogramcompared to baseline and EoT	52 weeks