US 10 mL Biologic Lung Volume Reduction (BLVR) Phase 1 Emphysema Study

• Status: Completed
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

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

Details

• Lead Sponsor: Aeris Therapeutics

Criteria

Inclusion Criteria:

• Clinical diagnosis of advanced heterogeneous emphysema

• Age >/= 40

• Clinically significant dyspnea

• Failure of standard medical therapy to relieve symptoms

• Pulmonary function tests with protocol-specified ranges

Exclusion Criteria:

• Alpha-1 protease inhibitor deficiency

• Tobacco use within 16 weeks of initial clinic visit

• Body mass index < 15 kg/m2 or > 35 kg/m@

• Clinically significant asthma, chronic bronchitis or bronchiectasis

• Allergy or sensitivity to tetracycline

• Prior lung volume reduction surgery, prior lobectomy or pneumonectomy, prior lung transplantation, prior endobronchial valve placement, prior airway stent placement or prior pleurodesis