Netherlands 10 mL Bronchoscopic Lung Volume Reduction (BLVR) Phase 1/2 Emphysema Study - Initial Formulation

• Include: Product-related life-threatening adverse events, permanently disabling complications and deaths [ Time Frame: 1 year post treatment ] [ Designated as safety issue: Yes ]
• FEV1 [ Time Frame: 12 weeks post treatment ] [ Designated as safety issue: No ]
• MRC Dyspnea Score [ Time Frame: 12 weeks post treatment ] [ Designated as safety issue: No ]
• Six-Minute Walk Test [ Time Frame: 12 week post treatment ] [ Designated as safety issue: No ]
• Health-Related Quality of Life [ Time Frame: 12 week post treatment ] [ Designated as safety issue: No ]

• Include: Product-related life-threatening adverse events, permanently disabling complications and deaths
• FEV1
• MRC Dyspnea Score
• Six-Minute Walk Test
• Health-Related Quality of Life Questionnaires
• Dose-response

• Include: Lung function tests [ Time Frame: 12 week post treatment ] [ Designated as safety issue: No ]
• Lung volume measurements [ Time Frame: 12 week post treatment ] [ Designated as safety issue: No ]

• Include: Lung function tests
• Lung volume measurements

The purpose of this study is to determine the effective dose of the Aeris BLVR System in patients with advanced emphysema.

Emphysema is a progressive, debilitating disease that affects nearly 3 million people in the United States or roughly one percent of the US population. The disease is 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 and occupational 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 in the United States. Currently there are 46 million smokers in the US. Due to the number of current and new smokers, emphysema is expected to remain a leading cause of morbidity and mortality in the United States for years to come.

Aeris has developed a novel bronchoscopic system for achieving the benefits of lung volume reduction without surgery. The Bronchoscopic Lung Volume Reduction (BLVR) Hydrogel System, a new investigational therapy for emphysema, is intended to reduce lung volume over a period of weeks by collapsing and promoting the remodeling of diseased areas of the lung. The resulting reduction in lung volume is intended to restore a more normal physiological relationship between lung and chest wall, improve breathing and exercise capacity and alleviate symptoms of chronic dyspnea. This study will evaluate the safety and efficacy of the Aeris BLVR System in patients with advanced emphysema.

Inclusion Criteria include:

• Clinical diagnosis of advanced emphysema
• Age > 18 years at the time of initial presentation
• Clinically significant dyspnea (MRC Dyspnea >/= 2)
• Laboratory tests within protocol-specified ranges
• Pulmonary function tests

Exclusion Criteria include:

• Alpha-1 protease inhibitor deficiency verified by a serum level of <80mg% or knowledge of PI*ZZ genotype
• Tobacco use within 16 weeks of the initial clinic visit
• Body mass index < 15 kg/m2 or > 35 kg/m2
• Clinically significant asthma (reversible airway obstruction), chronic bronchitis or bronchiectasis
• Allergy to fish or pork products or sensitivity to tetracycline
• FEV1 <20% predicted with DLCO <20% predicted or homogeneous disease