Clinical evidence
The clinical evidence for COPD balloon therapy
The published peer-reviewed studies on Broncho Muco Cleaner balloon dilation therapy and all of their outcomes — the measures that did not improve as well as those that did.
Last updated: 28 September 2026
In short
Broncho Muco Cleaner balloon dilation therapy has been examined in a prospective study published in a peer-reviewed journal. At 12 months, statistically significant improvement was reported in breathlessness, the number of moderate/severe exacerbations and quality-of-life scores. No significant change was found in lung function (FEV1) or 6-minute walk distance.
Every figure on this page comes from the publication linked beside it. No number has been published without a verifiable source.
What it improved at 12 months — and what it did not
The table below lists the 12-month outcomes of the prospective study published in the Journal of Clinical Medicine exactly as reported. Measures that did not improve have not been removed from the table.
| Measure | Outcome | p value |
|---|---|---|
| Breathlessness (mMRC scale) | Significant improvement | p<0.001 |
| Number of moderate/severe exacerbations | Significant reduction | p=0.022 |
| Quality of life (SGRQ symptom, activity, impact and total scores) | Significant improvement in all four scores | p<0.01 |
| Lung function (FEV1) | No significant change | p=0.291 |
| Exercise capacity (6-minute walk distance) | No significant change | p=0.420 |
A finding is considered statistically significant when the p value is below 0.05; above that threshold, the possibility that the measured change is due to chance cannot be excluded.
Source: Journal of Clinical Medicine, July 2026 · PMID 42513520.
Safety
The study reported a favourable safety profile over 12 months, with no procedure-related deaths reported. This does not mean the procedure carries no risk — bronchoscopy is an interventional procedure and its risks are assessed individually for each patient.
How bronchoscopic methods appear in the literature
Outcomes reported in the literature for bronchoscopic methods developed for chronic bronchitis-predominant COPD. Because each method was studied in different trials and different patient groups, this table is not a direct head-to-head comparison.
| Method | Symptoms and quality of life | Lung function | Exercise capacity |
|---|---|---|---|
| Balloon dilation (Broncho Muco Cleaner) | Significant improvement in mMRC (p<0.001); significant improvement in all four SGRQ scores (p<0.01); reduction in moderate/severe exacerbations (p=0.022) | No significant change in FEV1 (p=0.291) | No significant change in 6-minute walk distance (p=0.420) |
| Bronchial rheoplasty (RheOx) | CAT −7.9 points, SGRQ −14.6 points; gains maintained at month 12 | No significant change in lung function | — |
| Metered cryospray | SGRQ −6.4 points, CAT −3.8 points | — | Initial gain in 6-minute walk distance was not maintained at month 12 |
A “—” means no verified numerical data for that measure is presented on this page; it does not mean the method is ineffective in that area.
The balloon dilation row contains no point-based change; the verified data is at the level of statistical significance. CAT and SGRQ point values are given only for methods whose sources report them as points.
Independent reviews that assess these methods side by side are listed in the source list below.
Published studies and reviews
Every record below can be verified on PubMed; the links go directly to the source.
- Primary studyPMID 42513520
Prospective study of Broncho Muco Cleaner balloon dilation therapy
Efficacy and Safety of Broncho Muco Cleaner Balloon Dilation Therapy in Chronic Bronchitis-Predominant COPD: A Prospective Interventional Study
Journal: Journal of Clinical Medicine · July 2026
A peer-reviewed study examining the 12-month efficacy and safety of balloon dilation therapy in the chronic bronchitis-predominant COPD phenotype. Significant improvement was reported in breathlessness, exacerbation frequency and quality of life, while no significant change was found in lung function or exercise capacity.
Study design
Prospective interventional study. 35 patients: GOLD stage II–IV, chronic bronchitis-predominant COPD, inclusion criterion mMRC ≥ 2. Enrolment opened in February 2022, bronchoscopic interventions began in March 2022 and the study was completed in January 2025. Each patient received 3 intervention sessions, with follow-up at months 3, 6 and 12. 25 patients completed the 12-month follow-up.
Authors
Erdoğan Çetinkaya, Mustafa Çörtük, Demet Turan, Umut İlhan, Fulya Senem Karaahmetoğlu, Zeynep Betül Özcan, Barış Demirkol
Participating centres
- Yedikule Göğüs Hastalıkları ve Göğüs Cerrahisi Eğitim ve Araştırma Hastanesi
- Sağlık Bilimleri Üniversitesi Hamidiye
- Başakşehir Çam ve Sakura Şehir Hastanesi
Note on honesty
25 patients completed the 12-month follow-up. This scale does not remove the need for larger and comparative studies.
- Supporting publicationPMID 30508939
Larger follow-up series of 188 patients
Journal: Medicine (Baltimore) · November 2018
In a larger follow-up series of 188 patients, significant gains in FEV1, walking distance and quality of life, along with a reduction in exacerbations, were reported.
Note on honesty
This series reports a gain in FEV1, whereas the 2026 prospective study found no significant change in FEV1. The two findings are not consistent; we do not hide this, and for that reason we do not promise improvement in lung function.
- Supporting publicationPMID 26165891
Pilot study of the method (2015)
Use of Resector Balloon Desobstruction in Patients With Severe Chronic Obstructive Pulmonary Disease: A Pilot Study
Journal: Journal of Bronchology & Interventional Pulmonology · July 2015
An early pilot study investigating the feasibility of bronchoscopic balloon dilation in severe COPD. It forms the methodological basis on which later, larger series build.
Note on honesty
Because of their small patient numbers, pilot studies count as evidence of feasibility rather than evidence of efficacy.
- Congress abstract
European Respiratory Society (ERS) congress abstract
Efficacy and Safety of Broncho Muco Cleaner Balloon Dilatation Therapy in COPD (EXERTION®)
Journal: European Respiratory Journal · 64 (suppl 68): PA4352
The abstract in which efficacy and safety data for the method were presented at the European Respiratory Society congress.
Note on honesty
Congress abstracts go through a more limited review process than full-text peer-reviewed publications.
- Independent reviewPMID 36902641
Independent review — bronchoscopic options in chronic bronchitis
Modern Bronchoscopic Treatment Options for Patients with Chronic Bronchitis
Journal: Journal of Clinical Medicine · February 2023
An independent review that evaluates, side by side, the bronchoscopic treatment options developed for patients with chronic bronchitis.
Authors
Mayr AK, Valipour A
- Independent reviewPMID 33472961
Independent review — new bronchoscopic modalities
New bronchoscopic treatment modalities for patients with chronic bronchitis
Journal: European Respiratory Review · March 2021
An independent review examining the new bronchoscopic treatment modalities used in chronic bronchitis.
Authors
Hartman JE, Garner JL, Shah PL
Where the evidence ends
The strongest way to describe a method is to state where its evidence stops.
Balloon dilation therapy does not improve lung function: the prospective study found no significant change in FEV1 (p=0.291).
Exercise capacity did not improve either: there was no significant change in 6-minute walk distance (p=0.420).
The method does not cure COPD. It does not reverse permanent lung damage; smoking cessation, medication and pulmonary rehabilitation remain the foundation of treatment.
The method is not for every COPD patient. The published study was conducted in patients with the chronic bronchitis-predominant phenotype, GOLD stage II–IV and mMRC ≥ 2.
The publications are inconsistent: the larger series of 188 patients reported a gain in FEV1, whereas the prospective study found no significant change.
Eligibility is determined solely by a pulmonologist's assessment.
The study is a single-arm pre–post study in which each patient served as their own control. In the study's own words, the absence of a control group precludes attributing the observed improvements solely to this therapy.
The findings come from selected patient populations without randomized controlled comparisons, and confirmation in larger prospective studies with longer follow-up is still required.
Is this treatment controversial?
We address the criticisms raised about the method, point by point, against what the published data actually shows — on a separate page.
Criticisms and evidence-based answersRelated pages
Find out whether this treatment suits you
Contact us for a free preliminary assessment. Eligibility is decided by a physician after the necessary tests.
This content is for information only and does not replace a physician's examination. Consult a healthcare provider for diagnosis and treatment.