Netherlands 10 mL Bronchoscopic Lung Volume Reduction (BLVR) Phase 1/2 Emphysema Study - Initial Formulation
The purpose of this study is to determine the effective dose of the Aeris BLVR System in patients with advanced emphysema.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Dose Escalation Study of the Aeris Bronchoscopic Lung Volume Reduction (BLVR) System in Patients With Advanced Emphysema|
- 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: 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 ]
|Study Start Date:||May 2005|
|Study Completion Date:||May 2007|
|Primary Completion Date:||September 2006 (Final data collection date for primary outcome measure)|
Biological: BLVR Hydrogel
10 mL BLVR Hydrogel
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.