Israeli Biologic Lung Volume Reduction (BLVR) Phase 1 Emphysema Study

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and efficacy of the Biologic Lung Volume Reduction System (BLVR) for patients with advanced emphysema refractory to medical therapy.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aeris Therapeutics

Criteria

Inclusion Criteria:

• clinical diagnosis of advanced 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

• 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

• significant comorbidity