The Value of Bronchoscopic Lung Volume Reduction by Endobronchial Valves in Patients With Single Lung Transplantation and Overinflation of the Native Lung

Study Overview
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Brief Summary
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The purpose of the study is to investigate if bronchoscopic lung volume reduction by valves (Zephyr) would reduce native lung overinflation in patients that underwent single lung transplantation due to emphysema, and improve their well being and pulmonary function tests.

Detailed Description
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Emphysema is a progressive pulmonary disease characterized by abnormal and permanent enlargement of air spaces distal to terminal bronchioles accompanied by the destruction of pulmonary parenchyma. Treatment includes inhaled bronchodilator therapy, rehabilitation and/or oxygen treatment. In addition to the above, patients with severe emphysema may benefit from surgical lung volume reduction and/or lung transplantation. The rationale for lung volume reduction surgery is that reducing lung size would restore elastic recoil of the lung and improve chest wall and diaphragm mechanics. It has previously been shown that particularly patients with heterogeneous emphysema seem to benefit most from surgical lung volume reduction. Bronchoscopic lung volume reduction (BLVR) has recently been introduced as a less invasive potential alternative to surgical lung volume reduction. BLVR attempts to achieve the effects of surgery, by placing bronchial prostheses using a fibreoptic bronchoscope to selectively occlude the airways supplying the most affected hyperinflated regions of the emphysematous lung, while permitting exhaled gas to escape. This attempts to achieve segmental or lobar volume reduction, simulating the effects of surgical LVR. The purpose of the study is to investigate if bronchoscopic lung volume reduction by valves (Zephyr) would reduce native lung overinflation in patients that underwent single lung transplantation due to emphysema, and improve their well being and pulmonary function tests

Official Title
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Clinical Trial to Evaluate the Value of Bronchoscopic Lung Volume Reduction by Endobronchial Valves in Patients With Single Lung Transplantation and Overinflation of the Native Lung

Conditions
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Native Lung Overinflation in Patients That Underwent Single Lung Transplantation Due to Emphysema

Intervention / Treatment
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* Device: lung volume reduction using the Zephyr device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Single lung transplantation due to emphysema at least six months following transplantation that developed native lung overinflation Age from 40 to 75 years BMI < 32 kg/m2 FEV1 < 40% of predicted value, FEV1/FVC < 70% TLC > 120% predicted, RV > 150% predicted. Stable with < 20 mg prednisone (or equivalent) qd PaCO2 < 50mm Hg PaO2 > 45 mm Hg on room air 6-min walk of > 50m (without rehabilitation) or > 100m (with rehabilitation) Nonsmoking for 4 months prior to initial interview and throughout screening The patient agrees to all protocol required follow-up intervals. The patient has no child bearing potential The patient is willing and able to complete protocol required baseline assessments and procedures Exclusion criteria Prior endobronchial treatment for emphysema Pleural or interstitial disease that precludes surgery. Prior lung transplant, LVRS, median sternotomy, bullectomy or lobectomy. Clinically significant bronchiectasis Pulmonary nodule requiring surgery History of recurrent respiratory infections (> 3 hospitalization in the last year) Clinically significant (> 4 Tablespoons per day) sputum production Fever, elevated white cell count, or other evidence of active infection Dysrhythmia that might pose a risk during exercise or training Congestive heart failure within 6 mo and LVEF < 45% Evidence or history of Cor Pulmonale Resting bradycardia (< 50 beats/min), frequent multifocal PVCs, complex ventricular arrhythmia, sustained SVT History of exercise-related syncope MI within 6 mo and LVEF < 45% Evidence of systemic disease or neoplasia expected to compromise survival during 5-yr period Any disease or condition that interferes with completion of initial or follow-up assessments Patient is currently enrolled in another clinical trial Patient is unable to complete 3 minutes of unloaded peddling on cycle ergometer Alpha-1-Antitrypsin Deficiency

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention group<br>Patients that underwent dingle lung transplantation due to emphysema and developed native lung overinflation as demonstrated by chest CT and decline in pulmonary lung function tests (FEV1 ) shall undergo valves placement to the native lung | Device: lung volume reduction using the Zephyr device<br>* lung volume reduction using the Zephyr device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| •Mean % change in lung function (FEV1) |  | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in six minutes walk distance |  | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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emphysema, lung transplantation