US 10 mL Biologic Lung Volume Reduction (BLVR) Phase 2 Emphysema Study
Phase 2 Study of the Biologic Lung Volume Reduction System (BLVR) in Patients With Advanced Upper Lobe Predominant Emphysema
1 other identifier
interventional
20
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Feb 2007
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 7, 2007
CompletedFirst Posted
Study publicly available on registry
February 14, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedOctober 24, 2011
October 1, 2011
2.3 years
February 7, 2007
October 21, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Reduction in gas trapping
12 weeks post treatment
SAEs - Safety of treatment and the procedure
2 years
Secondary Outcomes (6)
Improvement in vital capacity
12 weeks post treatment
Improvement in expiratory flow
12 weeks post treatment
Improvement in inspiratory flow
12 weeks post treatment
Improvement in dyspnea symptoms (breathlessness)
12 weeks post treatment
Improvement in exercise capacity
12 weeks post treatment
- +1 more secondary outcomes
Study Arms (1)
BLVR Treatment
EXPERIMENTALBLVR Treatment
Interventions
Eligibility Criteria
You may qualify if:
- 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)
- Minute Walk Distance \>/= 150 m
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
University of Alabama Birmingham Lung Health Center
Birmingham, Alabama, 35249, United States
Pulmonary Associates
Phoenix, Arizona, 85006, United States
Caritas St Elizabeth's Med Cen
Boston, Massachusetts, 02135, United States
Temple University Lung Center
Philadelphia, Pennsylvania, 01940, United States
Medical University of South Carolina Hospital
Charleston, South Carolina, 29425, United States
Related Publications (3)
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. doi: 10.1164/rccm.200208-842OC. Epub 2002 Oct 11.
PMID: 12406835BACKGROUNDReilly 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. doi: 10.1378/chest.06-1754.
PMID: 17426216BACKGROUNDCriner GJ, Pinto-Plata V, Strange C, Dransfield M, Gotfried M, Leeds W, McLennan G, Refaely Y, Tewari S, Krasna M, Celli B. Biologic lung volume reduction in advanced upper lobe emphysema: phase 2 results. Am J Respir Crit Care Med. 2009 May 1;179(9):791-8. doi: 10.1164/rccm.200810-1639OC. Epub 2009 Jan 29.
PMID: 19179484DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Victor Pinto-Plata, MD
Steward St. Elizabeth's Medical Center of Boston, Inc.
- PRINCIPAL INVESTIGATOR
Gerard Criner, MD
Temple University Lung Center
- PRINCIPAL INVESTIGATOR
Mark Gotfried, MD
Pulmonary Associates
- PRINCIPAL INVESTIGATOR
Charlie Strange, MD
Medical Univ South Carolina Hospital
- PRINCIPAL INVESTIGATOR
Mark Dransfield, MD
Univ of Alabama Birmingham Lung Health Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 7, 2007
First Posted
February 14, 2007
Study Start
February 1, 2007
Primary Completion
June 1, 2009
Study Completion
June 1, 2009
Last Updated
October 24, 2011
Record last verified: 2011-10