US 10 mL Biologic Lung Volume Reduction (BLVR) Phase 2 Emphysema Study

Phase 2 Study of the Biologic Lung Volume Reduction System (BLVR) in Patients With Advanced Upper Lobe Predominant Emphysema

Evaluate the efficacy and safety of the 10 mL BLVR System in 1 or 2 treatment sessions (8 subsegments, 4 in each lung) in patients with advanced upper lobe predominant emphysema.

Prospective, open-label, non-controlled, multi-center Phase 2 Study evaluating the efficacy and safety of the 10 mL BLVR System in patients with advanced upper lobe predominant emphysema. Twenty patients will be divided into 2 groups of 10 patients each and treated under conscious sedation at a total of 8 subsegments. Group 1 will be treated in 4 subsegments in 1 lung and have a second treatment of 4 subsegments in the other lung 6 to 12 weeks later. Group 2 will receive treatment at 8 subsegments (4 in each lung) during a single treatment session if possible; if not completed in 1 session the remaining subsegments will be treated 6 to 12 weeks later. Patients will be followed 96 weeks after completion of the final BLVR treatment. All patients will receive standard medical therapy in addition to BLVR treatment.

Inclusion Criteria:

• clinical diagnosis of advanced upper lobe predominant emphysema
• age >/= 40 years
• clinically significant dyspnea
• failure of standard medical therapy to relieve symptoms (inhaled beta agonist and inhaled anticholinergic)
• pulmonary function tests within protocol-specified ranges (post bronchodilator FEV1 < 45% predicted and experiencing < 30% or 300 mL improvement using bronchodilator; TLC > 110% predicted; RV > 150% predicted)
• 6 Minute Walk Distance >/= 150 m

Exclusion Criteria:

• alpha-1 protease inhibitor deficiency
• homogeneous disease
• tobacco use within 4 months of initial visit
• body mass index < 15 kg/m2 or > 35 kg/m2
• clinically significant asthma, chronic bronchitis or bronchiectasis
• allergy or sensitivity to procedural components
• pregnant, lactating or unwilling to use birth control if required
• prior lung volume reduction surgery, lobectomy, pneumonectomy, lung transplant, endobronchial valve placement, airway stent placement or pleurodesis
• comorbid condition that could adversely influence outcomes
• inability to tolerate bronchoscopy under conscious sedation (or anesthesia)