An interventional study of Endoscopic lung volume reduction in 2 stages and Endoscopic lung volume reduction in 1 stage in COPD, sponsored by University Hospital, Limoges. Recruiting at 17 sites in France. Open to participants aged 35 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-06-23.
Sponsored by University Hospital, Limoges · Not applicable, Interventional, and Treatment
Chronic obstructive pulmonary disease (COPD) affects 3.5 million people and is the third leading cause of death worldwide. Emphysema involves air retention in the lungs and is ultimately responsible for a major deterioration in the quality of life. Available drug treatments have moderate efficacy whereas surgical lung volume reduction can improve exercise capacity when offered to a very selected population but at the cost of significant morbidity and mortality.
Endoscopic Lung Volume reduction with ZEPHYR® valves improves respiratory function at rest, exercise tolerance and quality of life in patients with little or no interlobar collateral ventilation.
If this technique has therefore proven its effectiveness, it is not devoid of complications and is notably responsible for pneumothorax in 27% of cases. The management of this complication is clearly codified, ranging from patient monitoring to the removal of one or more valves. It is therefore a subject of major concern for multiple reasons: high incidence, lengthening of hospital stay, increase in the overall cost of care, potential loss of benefit for the patient in the event of permanent withdrawal. valves and above all a potentially fatal event.
A new strategy for implanting ZEPHYR® valves in two stages has been developed in Limoges University Hospital. This innovative algorithm has been evaluated in several non-comparative single or multicenter studies. In those studies, pneumothorax' rate secondary to lung volume reduction with endobronchial valves is rated between 4.5 and 12%. The efficacy of the treatment appears to be comparable with the data found in the trials evaluating in which the entire lobe was treated in one procedure. Moreover, despite two procedures, there does not seem to be any increased risk of occurrence of other complications. Finally, the systematic scheduling of a thoracic computed tomography between the two procedures showed that 26.6% of patients presented a reduction in volume greater than 350mL despite incomplete treatment.
These data seem promising but no direct comparison with standard one-step treatment has ever been conducted so far.
The Zephyr® valve was first implanted in 2001. Since then, 5 important studies have proven a clinical superiority compared to the existing standard of care. Bronchoscopic lung-volume reduction with the use of one-way endobronchial valves is a potential treatment for patients with severe emphysema. Loss of lung elastic recoil leads to airflow obstruction, gas trapping, and increased operating lung volumes. Lung volume reduction surgery (LVRS), resection of the most affected of the lung, has been clearly shown to improve outcomes in selected patient groups. The surgical intervention is, however, associated with significant morbidity and an early mortality rate of about 5%. Therefore, there is considerable interest in developing novel treatment approaches that can reduce lung volume and gas trapping, either more safely than LVRS or in patients for whom LVRS is not an option.
In the present study, 244 patients will be randomized. After the selection process, they will all be hospitalized in order to undergo an endoscopic lung volume reduction with Zephyr® valve under general anesthesia. Half of them, the experimental group, will be treated according to Limoges' treatment algorithm (2 stages). For the other half, the control group, the entire lobe will be treated during one procedure will. Both groups will receive the standard of care treatments, according to the Global initiative for chronic Obstructive Lung Disease recommendations (GOLD).
Both groups will be followed for one year:
5,520 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 856 are open to participants now.
This study's planned enrollment of 244 is above the median of 62 across 3,839 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →University Hospital, Limoges is the lead sponsor of 264 studies on the registry; 38 are open to participants now.
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Patient able to give and participate in the study
Exclusion Criteria:
Pulmonary tomoscintigraphy:
Echocardiography:
secondary exclusion criteria:
- Evidence of collateral ventilation measured by the Chartis system
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: Endoscopic lung volume reduction in 2 stages
Procedure: Endoscopic lung volume reduction in 1 stage
After the selection process, they will all be hospitalized in order to undergo an endoscopic lung volume reduction with Zephyr® valve under general anesthesia. In the experimental group, patients will be treated according to Limoges' treatment algorithm (2 stages)
After the selection process, they will all be hospitalized in order to undergo an endoscopic lung volume reduction with Zephyr® valve under general anesthesia. In the control group, the entire lobe will be treated during one procedure
Pneumothorax rate
Proportion of patients suffering from at least one pneumothorax rate between the beginning and the first 45 days following the end of lung volume reduction with ZEPHYR® valves
Time frame: 45 day
Forced expiratory volume in one second (FEV1) measurement
Functional parameters at rest (plethysmography) - assessment of FEV1 in liter
Time frame: 0 Day, 45 Day, 6 month and 12 month
Force Vital Expiratory (FVE) measurement
Functional parameters at rest (plethysmography) - assessment of FVE in Liter
Time frame: 0 Day, 45 Day, 6 month and 12 month
Functional Residual Capacity (FRC) measurement
Functional parameters at rest (plethysmography) - assessment of FRC in Liter
Time frame: 0 Day, 45 Day, 6 month and 12 month
Inspiratory Capacity (IC) measurement
Functional parameters at rest (plethysmography) - assessment of IC in Liter
Time frame: 0 Day, 45 Day, 6 month and 12 month
Residual Volume (RV) measurement
Functional parameters at rest (plethysmography) - assessment of RV in Liter
Time frame: 0 Day, 45 Day, 6 month and 12 month
Residual Volume (RV) / Total Lung Capacity (TLC) ratio
Functional parameters at rest (plethysmography) - assessment of ration RV/TLC in Liter
Time frame: 0 Day, 45 Day, 6 month and 12 month
Exercise tolerance
6 minutes walking test
Time frame: 0 Day, 45 Day, 6 month and 12 month
Quality of life questionnaire
EuroQol 5-Digit 5-level (EQ-5D-5L) questionnaire
Time frame: 0 Day, 45 Day, 6 month and 12 month
Quality of life questionnaire
COPD Assessment Test (CAT). Minimum score is 0 and maximum is 40
Time frame: 0 Day, 45 Day, 6 month and 12 month
Quality of life questionnaire
Saint-George Respiratory Questionnaire (SGRQ)
Time frame: 0 Day, 45 Day, 6 month and 12 month
lobe volume reduction
Target lobe volume reduction by Thorax scanner
Time frame: 45 Day
Respiratory events
Study of morbidity and mortality. number of Respiratory events
Time frame: 12 month
Events related to the valves
Study of morbidity and mortality. number of events related to the valves
Time frame: 12 month
Revision bronchoscopies
Study of morbidity and mortality. Numbers of revision bronchoscopies
Time frame: 12 month
Death
Study of morbidity and mortality. numbers of death
Time frame: 12 month
responder's rate
In the experimental arm, responder's rate after the first procedure (despite infralobar treatment) defined by: * Plethysmography * FEV1: Improvement of equal or more than 12% * RV: Decrease of equal or more than 430mL * Thorax CT scan: target lobe volume reduction rated at more than 350mL.
Time frame: 12 month
Incremental Cost-Utility Ratio (ICUR)
Incremental Cost-Utility Ratio (ICUR) of the 2 intervention strategies expressed in euros per QALY gained in 12 months. The ICUR will be calculated on the basis of the following data: Quality of life assessed by the EQ-5D-5L questionnaire. Direct medical costs.
Time frame: 12 month
Plan to share: No
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