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

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study it to evaluate the efficacy and safety of the 20 mL BLVR System in patients with advanced upper lobe predominant emphysema.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aeris Therapeutics

Criteria

Inclusion Criteria:

• clinical diagnosis of advanced upper lobe emphysema

• age >/= 40 years

• clinically significant dyspnea

• failure of standard medical therapy to relieve symptoms (inhaled beta agonist & inhaled anticholinergic)

• pulmonary function tests within protocol-specified ranges (post bronchodilator FEV1 < 45% predicted & experiencing < 30% or 300 mL improvement using bronchodilator; total lung capacity > 110% predicted; residual volume > 150% predicted)

• 6 Minute Walk Distance >/= 150 m

Exclusion Criteria:

• alpha-1 protease inhibitor deficiency

• homogeneous emphysema

• 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, endotracheal valve placement, airway stent placement or pleurodesis

• comorbid condition that could adversely influence outcomes

• inability to tolerate bronchoscopy under conscious sedation (or anesthesia)

• history of renal infarction or renal failure