Efficacy and Safety of Broncho Muco Cleaner Balloon Dilation Therapy (NCT05868941) | Clinical Trial Compass
CompletedNot Applicable
Efficacy and Safety of Broncho Muco Cleaner Balloon Dilation Therapy
Turkey (Türkiye)35 participantsStarted 2022-02-02
Plain-language 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.
Who can participate
Age range
40 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 l…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Reliability of the procedure - Safety
Timeframe: 52 weeks
2
Patients' Tolerence - mMRC dyspnea scale
Timeframe: 52 Weeks
3
Patients' Tolerence - COPD Exacerbation Number (severity of exacerbation will be indicated as mild, moderate, severe.)
Timeframe: 52 Weeks
4
Patients' Tolerence - St George Respiratory Questionnaire
Timeframe: 52 Weeks
5
Patients' Tolerence - 6 min walking test
Timeframe: 52 Weeks
6
Patients' Tolerence - Pulmonary Function Test (FEV1, FVC values in (lt) and (%) values as well as FEV1/ FVC rate (in %)