Status:
COMPLETED
Biologic Lung Volume Reduction (BLVR) Phase 2 Homogeneous Study
Lead Sponsor:
Aeris Therapeutics
Conditions:
Homogeneous Emphysema
Eligibility:
All Genders
40+ years
Phase:
PHASE2
Brief Summary
The purpose of the study is to evaluate the efficacy and safety of the 20 mL BLVR System in patients with homogeneous emphysema. Patients with upper lobe predominant emphysema initially screened for e...
Detailed Description
Patients with emphysema currently have limited treatment choices. Many patients are treated with steroids and inhaled medications, which often provide little or no benefit. In recent years, lung volum...
Eligibility Criteria
Inclusion
- clinical diagnosis of advanced homogeneous or upper lobe predominant emphysema demonstrated by CT scan
- age \>/= 40 years
- clinically significant dyspnea
- failure of standard medical therapy (typically inhaled beta agonist \& inhaled anticholinergic) to relieve symptoms
- 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
- tobacco use within 4 months of initial visit or during study
- 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 lung perfusion scan indicating \> 20% of blood flow to either upper lung field or 30% total to both upper lung fields if homogeneous emphysema
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00630227
Start Date
February 1 2008
End Date
December 1 2009
Last Update
October 24 2011
Active Locations (8)
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1
University of Alabama
Birmingham, Alabama, United States, 35249
2
Pulmonary Associates
Phoenix, Arizona, United States, 85006
3
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States, 52242
4
Veritas Clinical Specialties
Topeka, Kansas, United States, 66606