AeriSeal® System 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 procedural and post-procedural safety and efficacy of AeriSeal therapy at up to 4 subsegments during a single treatment session in patients with GOLD Stage III/IV homogeneous or heterogeneous emphysema.

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 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, 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 a diagnosis of advanced emphysema as defined by FEV1/FVC<70% predicted, FEV1 of <50% predicted, TLC > 100% predicted, and RV > 135% predicted. Patients must have persistent symptoms despite medical therapy and either not be candidates for Lung Volume Reduction Surgery (LVRS) or have elected not to undergo LVRS. Patients must be > 40 years of age, have symptoms despite medical therapy, and have none of the prespecified co-morbid conditions that could influence study outcomes or their ability to tolerate bronchoscopy. Exclusion Criteria: -

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|The AeriSeal System will be Administered at 3 to 4 Pulmonary Subsegments During a Single Treatment session.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Percent Volume of Lung | Computed Tomography (CT) evidence of lobar volume reduction at site(s) of AeriSeal Foam Sealant administration at 12 weeks post treatment, assessed quantitatively by digital integration of CT dicom images collected using a standardized image acquisition and reconstruction algorithm. | 12 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 12 weeks in RV/TLC | 12 weeks following treatment | 
| Change in Forced Expiratory Volume in 1 Second (FEV1) | Change from baseline at 12 weeks in FEV1 | 12 weeks following treatment | 
| Change in Forced Vital Capacity (FVC) | Change from baseline at 12 weeks in FVC | 12 weeks following treatment | 
| Change in distance walked in six minutes | Change from baseline at 12 weeks in 6 Minute Walk Test (6MWT) | 12 weeks following treatment | 
| Change in Medical Research Council Dyspnea (MRCD) score | Change from baseline at 12 weeks in MRCD score | 12 weeks following treatment | 
| Change in St. George's Respiratory Questionnaire (SGRQ) domain score | Change from baseline at 12 weeks in SGRQ total domain score | 12 weeks following treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PLVR, BLVR, AeriSeal, treatment, device, breathing, COPD, emphysema, polymeric lung volume reduction, biologic lung volume reduction, heterogeneous, homogeneous, Pathologic Processes, Respiratory Tract Diseases, Lung Diseases, Pulmonary Disease, Chronic Obstructive