COPDEXERTIONNCT05868941
Efficacy and Safety of Broncho Muco Cleaner Balloon Dilation Therapy
A study testing Broncho Muco Cleaner in people with COPD, run by Clinodevice at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- COPD
- What is being tested?
- Broncho Muco Cleaner
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Feb 2022to 23 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 22Show fewer
- 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 locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital
Istanbul
About this study
Official title: 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.
- Conditions
- COPD
- Being tested
- Broncho Muco Cleaner
- Keywords
- Chronic Bronchitis, Medical Device, Baloon Dilatation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Bronchitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Broncho Muco CleanerDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Broncho Muco Cleaner | Experimental | 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 Receives: Device: Broncho Muco Cleaner |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reliability of the procedure - Safety
Reliability of the procedure (adverse events occurring) for 52 weeks post-procedure.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 52 Weeks
Secondary outcomes (4)
Improvement in functional parameters - 6 Minute Walk Test (V1-V6)
- 6 Minute Walk Test (V1-V6)
Measured: 52 weeks
Improvement in functional parameters - Pulmonary Function Test (V1-V2-V3-V4-V5-V6)
- Pulmonary Function Test (V1-V2-V3-V4-V5-V6)
Measured: 52 weeks
Adverse events
Adverse events seen (AE)
Measured: 52 weeks
Changes in laboratory test results
Change in blood chemistry tests and hemogramcompared to baseline and EoT
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start2 Feb 2022
- Primary completion17 Mar 2025
- Study completion23 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study is a multicenter, prospective local medical device clinical trial.
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinodevice
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Klinar CRO
- Responsible party
- Sponsor
- Investigators
- Erdogan Cetinkaya, Principal investigator, stanbul Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05868941
- Sponsor's protocol ID
- K-BB001-EXERTION
- Acronym
- EXERTION
- Status last verified
- Jun 2025
- First submitted
- 24 Feb 2022
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Broncho Muco Cleaner Balloon Dilation Therapy in Chronic Bronchitis-predominant COPD Cases
- ClinicalTrials.gov ID
- NCT05868941
- Acronym / sponsor ID
- EXERTION / K-BB001-EXERTION
- Conditions
- COPD
- Keywords
- Chronic Bronchitis, Medical Device, Baloon Dilatation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- ClinodeviceIndustry (pharma, biotech, devices)
- Collaborators
- Klinar CRO
- Study start
- 2 Feb 2022 (actual)
- Primary completion
- 17 Mar 2025 (actual)
- Study completion
- 23 Jun 2025 (actual)
- First posted
- 22 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study is a multicenter, prospective local medical device clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Broncho Muco Cleaner | Experimental | Device: Broncho Muco CleanerIt 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 |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (22 listed)
- be under the age of 40 and over the age of 75
- pregnant patients
- breastfeeding a child
- Being an active smoker
- Concurrent asthma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Broncho Muco CleanerThe 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. | Device | Broncho Muco Cleaner |
Primary outcome
Reliability of the procedure - Safety
Time frame: 52 weeks
Reliability of the procedure (adverse events occurring) for 52 weeks post-procedure.
Patients' Tolerence - mMRC dyspnea scale
Time frame: 52 Weeks
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.
Patients' Tolerence - COPD Exacerbation Number (severity of exacerbation will be indicated as mild, moderate, severe.)
Time frame: 52 Weeks
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
Patients' Tolerence - St George Respiratory Questionnaire
Time frame: 52 Weeks
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.
Patients' Tolerence - 6 min walking test
Time frame: 52 Weeks
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.
Patients' Tolerence - Pulmonary Function Test (FEV1, FVC values in (lt) and (%) values as well as FEV1/ FVC rate (in %)
Time frame: 52 Weeks
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.
Detection of Execerbations
Time frame: 52 weeks
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.
Quality of Life for the device
Time frame: 52 Weeks
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.
4 secondary outcomes
Improvement in functional parameters - 6 Minute Walk Test (V1-V6)
Time frame: 52 weeks
Improvement in functional parameters - Pulmonary Function Test (V1-V2-V3-V4-V5-V6)
Time frame: 52 weeks
Adverse events
Time frame: 52 weeks
Changes in laboratory test results
Time frame: 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erdogan Cetinkaya principal investigator
stanbul Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Broncho Muco Cleaner in people with COPD, run by Clinodevice at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reliability of the procedure - Safety (time frame: 52 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.