Pulmonary Emphysema Clinical Trial
Official title:
Phase 2 Study of the Biologic Lung Volume Reduction System (BLVR) in Patients With Advanced Upper Lobe Predominant Emphysema
Verified date | October 2011 |
Source | Aeris Therapeutics |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | June 2009 |
Est. primary completion date | June 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years and older |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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) |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Alabama Birmingham Lung Health Center | Birmingham | Alabama |
United States | Caritas St Elizabeth's Med Cen | Boston | Massachusetts |
United States | Medical University of South Carolina Hospital | Charleston | South Carolina |
United States | Temple University Lung Center | Philadelphia | Pennsylvania |
United States | Pulmonary Associates | Phoenix | Arizona |
Lead Sponsor | Collaborator |
---|---|
Aeris Therapeutics |
United States,
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 | Reduction in gas trapping | 12 weeks post treatment | No | |
Primary | SAEs - Safety of treatment and the procedure | 2 years | Yes | |
Secondary | Improvement in vital capacity | 12 weeks post treatment | No | |
Secondary | Improvement in expiratory flow | 12 weeks post treatment | No | |
Secondary | Improvement in inspiratory flow | 12 weeks post treatment | No | |
Secondary | Improvement in dyspnea symptoms (breathlessness) | 12 weeks post treatment | No | |
Secondary | Improvement in exercise capacity | 12 weeks post treatment | No | |
Secondary | Improvement in respiratory quality of life | 12 weeks post treatment | No |
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