Clinical Study to Evaluate the Exercise Capacity in Patients With Severe Emphysema Treated With Coils

Study Overview
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Brief Summary
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The study hypothesis is that patients with homogeneous emphysema behave differently compared to heterogeneous emphysema with respect to exercise capacity. A better understanding of this difference will allow the investigators to choose the best treatment for each type of patient. The main purpose of this study is to evaluate the change in exercise capacity measured by cycle ergometry in patients with severe emphysema after endoscopic lung volume reduction with coils (eLVR). As a secondary purpose, the investigators want to perform an exploratory, randomized study to compare the results of two different therapeutic approaches in a small sample of patients with homogeneous emphysema.

Detailed Description
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The study plans to include patients with severe emphysema candidates to go through eLVR with coils that fulfill all inclusion criteria and none of the exclusion criteria. Patients with both homogeneous and heterogeneous emphysema will be included. The main study intervention is the performance of a cyclo ergometry (not included in daily clinical practice) before (basal) and 6 months after going through the eLVR with coils. The subgroup of patients with homogeneous emphysema will be randomly assigned to the following therapeutic approaches: Group A: treatment with 10 coils in upper lobes Group B: treatment with 15 coils spared in upper and lower lobes Thus, the study includes: for all patients, the performance of two cycloergometries, before and 6 months after the eLVR Also, for the subset of homogeneous emphysema patients, an open label, randomized, parallel, two arm exploratory clinical trial. Sample size has not been formally calculated as there are no previous available data for the primary endpoint (change inspiratory capacity). Thus, 35 patients will be included according to the expected number of patients. Recruitment period will be 24 months and patient follow up will be 6 months.

Official Title
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Clinical Study to Evaluate the Exercise Capacity in Patients With Severe Emphysema Treated With Coils

Conditions
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Pulmonary Emphysema

Intervention / Treatment
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* Procedure: 10 coils in upper lobes
* Procedure: 15 coils in upper and lower lobes
* Procedure: cycloergometry


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Emphysematous patient FEV1 < 50% RV > 200% Diffusion <60% >20% PSP <55 mmHg Exclusion Criteria: Anticoagulants/antiplatelets Giant bullae (> 8 cm , 1/3 hemithorax) More tan three moderate/severe exacerbation per year Negative to sign informed consent

Ages Eligible for Study
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Minimum Age: 40 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 10 coils in upper lobes<br>10 coils in upper lobes | Procedure: 10 coils in upper lobes<br> <br> Procedure: cycloergometry<br> <br> |
| Experimental: 15 coils in upper and lower lobes<br>15 coils in upper and lower lobes | Procedure: 15 coils in upper and lower lobes<br> <br> Procedure: cycloergometry<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Inspiratory Capacity (L) | Change in Inspiratory Capacity (L) at 6 months from baseline | three months before procedure and six months after first procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RV (L) | Residual Volume (L) | three months before procedure and six months after first procedure | 
| 6-MWT (m) | Six minute walk test (m) | three months before procedure and six months after first procedure | 
| SGQLT (measured in points) | Saint George quality of life test (points) | three months before procedure and six months after first procedure | 
| FEV1(measured in liters) | Forced Expiratory Volume in 1 Second (L) | three months before procedure and six months after first procedure | 
| FVC (measured in liters) | Forced Vital Capacity (L) | three months before procedure and six months after first procedure | 
| Endoscopic Volume Reduction-Associated Complications Rate | Endoscopic Volume Reduction Complications Rate | 6 months | 
| Cycloergometry-associated Complications Rate | Cycloergometry-associated Complications Rate | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pulmonary emphysema, coils, cycloergometry, lung volume reduction