Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Phase 1 Study of the Biologic Lung Volume Reduction (BLVR) System in Patients With Advanced Emphysema
Verified date | January 2010 |
Source | Aeris Therapeutics |
Contact | n/a |
Is FDA regulated | No |
Health authority | Israel: Ministry of Health |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 16 |
Est. completion date | March 2009 |
Est. primary completion date | March 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years and older |
Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Israel | Rabin Medical Center | Petach Tivka |
Lead Sponsor | Collaborator |
---|---|
Aeris Therapeutics |
Israel,
Ingenito EP, Berger RL, Henderson AC, Reilly JJ, Tsai L, Hoffman A. Bronchoscopic lung volume reduction using tissue engineering principles. Am J Respir Crit Care Med. 2003 Mar 1;167(5):771-8. Epub 2002 Oct 11. — View Citation
Reilly J, Washko G, Pinto-Plata V, Velez E, Kenney L, Berger R, Celli B. Biological lung volume reduction: a new bronchoscopic therapy for advanced emphysema. Chest. 2007 Apr;131(4):1108-13. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | SAEs - Safety of treatment and the procedure | 1 year | Yes | |
Secondary | Reduction in gas trapping | 12 weeks | No | |
Secondary | Improvement in exercise capacity | 12 weeks | No | |
Secondary | Improvement in lung function (vital capacity) | 12 weeks | No | |
Secondary | Improvement in lung function (expiratory flow) | 12 weeks | No | |
Secondary | Improvement on dyspnea symptoms | 12 weeks | No | |
Secondary | Improvement in quality of life | 12 weeks | No |
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