Endoscopic Long Volume Reduction by Endobronchial Valves in Belgium

Study Overview
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Brief Summary
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This a single center non-randomised non-sham controlled intervention study evaluating the effectiveness and safety of endoscopic lung volume reduction by endobronchial valves

Detailed Description
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The primary objective of the current study is to explore the effect of targeted lobar endobronchial lung volume reduction in symptomatic patients with severe emphysema and absent collateral ventilation, on lung function, exercise capacity and physical activity. As a secondary objective, changes in physical activity as result of a 3 month activity coaching program delivered between 3 to 6 months post intervention will be investigated. Exploratory objectives are to extend insight in the clinical characteristics of responders and non-responders and to address relationships between lung function response, physical functioning and its impact on inflammation, skeletal and cardiac function. Furthermore, comparison of the effects on lung function, exercise capacity, quality of life and physical activity between endoscopic lung volume reduction and surgical lung volume reduction will be made. The study will also explore if treatment response can be optimised by an intermediate evaluation with CT scan one month after intervention. Endoscopic evaluation and repositioning of the endobronchial valves will be imposed in case no lober atelectasis is visualised. .

Official Title
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Endoscopic Long Volume Reduction by Endobronchial Valves in Belgium

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Device: endobronchial valves
* Behavioral: physical activity tele coaching
* Procedure: Lung volume reduction surgery (LVRS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 40 - 75 years Confluent or destructive heterogeneous emphysema on CT Smoking cessation for at least 6m (proven by urinary cotinine levels) FEV1 < 60 %predicted, RV > 150 %predicted, TLC > 90 %predicted RV/TLC ratio ≥ 0.55 6MWD < 450 meter mMRC ≥ 2 Visual estimation of 70% complete fissure between target lobe and adjacent lobe on CT of referring physician LABA-LAMA bronchodilator therapy as a minimum therapy Able to sign informed consent Exclusion Criteria: Homogenous emphysema PaCO2 > 60 mmHg with ambient air PaO2 < 45 mmHg with ambient air Previous LVRS, lung transplantation, lobectomy TLCO or FEV1 < 20% predicted Significant pulmonary hypertension (PaPsyst > 50 mm Hg) Heart failure with reduced EF (< 40%) 6MWD < 100 meter BODE index ≥ 7 and eligible for transplantation Active cancer Life expectancy < 3 months Significant lung disease other than COPD/emphysema Unable to comply with study procedures

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: control<br>standard care in case collateral ventilation is observed (by Chartis) with 3 months physical activity tele coaching between 3 and 6 months post allocation. | Behavioral: physical activity tele coaching<br>* 3 month physical activity tele coaching intervention consisting of a project tailored smartphone application in combination with a step counter providing direct feedback.<br>Procedure: Lung volume reduction surgery (LVRS)<br>* Patients not eligible for endoscopic lung volume reduction (or non responders of this intervention) can be referred for surgical lung volume reduction. With this procedure, the most emphysematous parts of the lungs will be surgically removed.<br>|
| Experimental: Endobronchial valves<br>Endobronchial valves in case collateral ventilation is absent (by Chartis) with 3 months physical activity tele coaching between 3 and 6 months post intervention. | Device: endobronchial valves<br>* A ambulatory diagnostic bronchoscopy under general anesthesia will evaluate the presence or absence of collateral ventilation . The targeted lobar airway is temporarily occluded by means of a balloon catheter, which blocks inspiratory flow but allows expiratory flow, in order to assess whether the air flow gradually declines to zero, meaning absence of collateral ventilation. Only in case collateral ventilation is excluded, a therapeutic bronchoscopy will be scheduled to insert the one-directional endobronchial valves in the targeted lobar airways. We will only perform a unilateral intervention during which we will treat one or maximal two lobes at one side.<br>Behavioral: physical activity tele coaching<br>* 3 month physical activity tele coaching intervention consisting of a project tailored smartphone application in combination with a step counter providing direct feedback.<br>Procedure: Lung volume reduction surgery (LVRS)<br>* Patients not eligible for endoscopic lung volume reduction (or non responders of this intervention) can be referred for surgical lung volume reduction. With this procedure, the most emphysematous parts of the lungs will be surgically removed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response rate of FEV1 at 3 months post intervention | proportion of patients with a minimal change of FEV1 > 100 ml | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response rate on SGRQ at 3 months and 6 months post intervention | proportion of patients with a minimal change of -4 points on SGRQ | 3 months and 6 months post intervention | 
| response rate on 6 minutes walking distance (6MWD) at 3 months and 6 months post intervention | proportion of patients with a minimal improvement of 30 meters on 6MWD | 3 months and 6 months post intervention | 
| response rate on residual volume (RV) at 3 months and 6 months post intervention | proportion of patients with a minimal reduction of 400 ml on residual volume | 3 months and 6 months post intervention | 
| response rate on FEV1 at 6 months post intervention | proportion of patients with a minimal change of FEV1 > 100 ml | 6 months | 
| response rate on Transitional dyspnee index (TDI) at 3 months and 6 months post intervention | proportion of patients with a minimal change of -1 point on TDI | 3 months and 6 months post intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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valves, Chronic Obstructive Pulmonary Disease, endoscopic long volume reduction