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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: COPD
• Intervention / Treatment: Device: Broncho Muco Cleaner

• Study Type: Interventional
• Enrollment (Estimated): 35
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tuba Kılıç; Phone Number: 90 533 730 90 28; Email: tubak@klinar-cro.com

Study Locations

• Turkey
  • Istanbul, Turkey
    • Istanbul Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reliability of the procedure - Safety	Reliability of the procedure (adverse events occurring) for 52 weeks post-procedure.	52 weeks
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
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
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in functional parameters - 6 Minute Walk Test (V1-V6)	- 6 Minute Walk Test (V1-V6)	52 weeks
Improvement in functional parameters - Pulmonary Function Test (V1-V2-V3-V4-V5-V6)	- Pulmonary Function Test (V1-V2-V3-V4-V5-V6)	52 weeks
Adverse events	Adverse events seen (AE)	52 weeks
Changes in laboratory test results	Change in blood chemistry tests and hemogramcompared to baseline and EoT	52 weeks

Collaborators and Investigators

• Sponsor: Clinodevice
• Collaborators: Klinar CRO
• Investigators: Principal Investigator: Erdogan Cetinkaya, stanbul Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2022
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: February 24, 2022
• First Submitted That Met QC Criteria: May 11, 2023
• First Posted (Actual): May 22, 2023

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 7, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Chronic Bronchitis; Medical Device; Baloon Dilatation
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Bronchitis
• Other Study ID Numbers: K-BB001-EXERTION

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No