The Use of Aeriseal ® in the Management of Collateral Ventilation Positive COPD Patients Undergoing ELVR Utilizing Endobronchial Valves.

Study Overview
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Brief Summary
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The aim of this study is to determine the feasibility of combining a lung sealant with endobronchial valves EBV in managing patients with COPD who are collateral ventilation (CV) positive. This study has two arms; arm 1 is for CV positive participants who will receive the lung sealant and EBV; arm 2 is the CV negative group who will only receive EBV as the standard management.

Official Title
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The Use of Aeriseal ® in the Management of Collateral Ventilation Positive COPD Patients Undergoing ELVR (Endoscopic Lung Volume Reduction) Utilizing Endobronchial Valves

Conditions
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Chronic Obstructive Pulmonary Disease (COPD)

Intervention / Treatment
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* Device: Lung Sealant
* Device: Endobronchial Valve (EBV)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: i. 18-85 years of age ii. Forced Expiratory Volume in 1second (FEV1) 20 - 50% iii. Residual Volume (RV) > 175% iv. 6 min walk test > 150 m v. Completed a course of Pulmonary rehabilitation vi. STRATX assessment - Left Upper Lobe as the most appropriate lobe to target for ELVR vii. This study will be investigating heterogenous emphysema only. Minimum of 15% differential in emphysema destruction scores at -950 HU Exclusion Criteria: i. Acute uncontrolled medical illness including ischemic heart disease, cardiac failure, acute renal impairment ii. Acute respiratory tract infections iii. Significant bronchiectasis, iv. Co-existing interstitial lung diseases, pneumothorax, v. Known active malignancy vi. Pregnancy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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
Interventional Model Description: Participants diagnosed as either Collateral Ventilation (CV) Negative or CV Positive. CV Negative participants will only receive the endobronchial valves (EBV). CV Positive participants will receive both the lung sealant and the EBV.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Collateral Ventilation Negative<br>Collateral Ventilation Negative participants will have endobronchial valve implant | Device: Endobronchial Valve (EBV)<br>* The Zephyr EBV System are one way valves inserted into the airways to reduce lung hyperinflation.<br>* Other names: Zephyr Endobronchial Valve System;|
| Experimental: Collateral Ventilation Positive<br>Collateral Ventilation Positive participants will have the lung sealant applied and the endobronchial valve implant | Device: Lung Sealant<br>* The Aeriseal System uses a polymer foam to block or seal fissures, peripheral airways, alveoli, and collateral channels to achieve lung volume reduction.<br>* Other names: AeriSeal;Device: Endobronchial Valve (EBV)<br>* The Zephyr EBV System are one way valves inserted into the airways to reduce lung hyperinflation.<br>* Other names: Zephyr Endobronchial Valve System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants converted from Collateral Ventilation positive (CV+) to Collateral Ventilation negative (CV-) | Collateral ventilation status will be functionally assessed and confirmed via CHARTIS® System. Examination of left upper lobe to determine percentage of participants converted from collateral ventilation positive to a collateral ventilation negative state | 4 weeks post lung sealant application | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with improved lung functioning as measured by lung function tests | Lung function will be assessed by spirometry, plethysmography, lung diffusion capacity and capillary blood test | 12weeks and 52 weeks post valve implant | 
| Changes Lung volume | Changes in lung volume will be assessed using high resolution computed tomography (HRCT) and target lobe volume reduction (TLVR) | 12weeks and 52 weeks post valve implant |