Status:
COMPLETED
US 10 mL Biologic Lung Volume Reduction (BLVR) Phase 1 Emphysema Study
Lead Sponsor:
Aeris Therapeutics
Conditions:
Pulmonary Emphysema
Eligibility:
All Genders
40+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety of the Biologic Lung Volume Reduction System (BLVR) for patients with advanced emphysema.
Detailed Description
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 l...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00347659
Start Date
June 1 2006
End Date
September 1 2007
Last Update
March 6 2008
Active Locations (2)
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1
Caritas St. Elizabeth's Medical Center
Boston, Massachusetts, United States, 02135
2
Temple University Lung Center
Philadelphia, Pennsylvania, United States, 19140