Status:
COMPLETED
US 10 mL Biologic Lung Volume Reduction (BLVR) Phase 2 Emphysema Study
Lead Sponsor:
Aeris Therapeutics
Conditions:
Pulmonary Emphysema
Eligibility:
All Genders
40+ years
Phase:
PHASE2
Brief Summary
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.
Detailed Description
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 patie...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00435253
Start Date
February 1 2007
End Date
June 1 2009
Last Update
October 24 2011
Active Locations (5)
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1
University of Alabama Birmingham Lung Health Center
Birmingham, Alabama, United States, 35249
2
Pulmonary Associates
Phoenix, Arizona, United States, 85006
3
Caritas St Elizabeth's Med Cen
Boston, Massachusetts, United States, 02135
4
Temple University Lung Center
Philadelphia, Pennsylvania, United States, 01940