A Continuation Study of the AeriSeal® System Administered at 3 to 4 Sites During a Single Treatment Session for Lung Volume Reduction in Patients With Advanced Emphysema

Study Overview
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Brief Summary
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The purpose of this study is to assess the long term safety and efficacy of AeriSeal System treatment administered at up to 4 subsegments during a single treatment session for lung volume reduction in patients with advanced emphysema through 48 weeks after treatment.

Detailed Description
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Emphysema is a progressive, debilitating disease characterized by destruction of lung tissue as a result of inflammation caused by exposure to noxious inhaled agents for extended periods. The most common cause of this condition is cigarette smoking, although genetic, occupational, and environmental causes account for up to 10% of cases. Despite aggressive public health initiatives aimed at discouraging the use of cigarettes, smoking-related lung diseases remain a significant cause of disability and death worldwide. Due to the number of current and new smokers, emphysema is expected to remain a leading cause of morbidity and mortality for years to come. The AeriSeal System is a novel device system being developed for the treatment of advanced emphysema. The AeriSeal System is administered bronchoscopically, and designed to provide the physiological benefits of lung volume reduction without the risks and cost of major surgery.

Official Title
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A Continuation Study of the AeriSeal® System Administered at 3 to 4 Sites During a Single Treatment Session for Lung Volume Reduction in Patients With Advanced Emphysema

Conditions
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Pulmonary Emphysema, Chronic Obstructive Pulmonary Disease(COPD), Lung Diseases

Intervention / Treatment
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* Device: AeriSeal System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must have been enrolled in the 03-C10-002PLV Aeris' Investigational Study and completed a minimum of 12 weeks of follow-up following AeriSeal System treatment.

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: AeriSeal System|Not applicable. Follow-Up study only.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Percent Volume of Lung | Computed Tomography (CT) evidence of lobar volume reduction at site(s) of AeriSeal Foam Sealant administration at 48 weeks post treatment, assessed quantitatively by digital integration of CT dicom images collected using a standardized image acquisition and reconstruction algorithm. | 48 Weeks following treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the ratio of Residual Volume (RV) to Total Lung Capacity (TLC) | Change from baseline at 24 and 48 weeks in RV/TLC | 24 and 48 weeks following treatment | 
| Change in Forced Expiratory Volume in 1 Second (FEV1) | Change from baseline at 24 and 48 weeks in FEV1 | 24 and 48 weeks following treatment | 
| Change in Forced Vital Capacity (FVC) | Change from baseline at 24 and 48 weeks in FVC | 24 and 48 weeks following treatment | 
| Change in distance walked in six minutes | Change from baseline at 24 and 48 weeks in 6 Minutes Walk Test (6MWT) | 24 and 48 weeks following treatment | 
| Change in Medical Research Council Dyspnea (MRCD) score | Change from baseline at 24 and 48 weeks in MRCD score | 24 and 48 weeks following treatment | 
| Change in St. George's Respiratory Questionnaire (SGRQ)domain score | Change from baseline at 24 and 48 weeks in SGRQ total domain score | 24 and 48 weeks following treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Polymeric Lung Volume Reduction (PLVR), Bolilogic Lung Volume Reduction (BLVR), AeriSeal, treatment, device, breathing, COPD, emphysema, heterogeneous, homogeneous, Pathologic Processes, Respiratory Tract Diseases, Lung Diseases, Pulmonary Disease, Chronic Obstructive