US Biologic Lung Volume Reduction (BLVR) Phase 2 Emphysema Study
Phase 2 Study of the 20 mL Biologic Lung Volume Reduction System (BLVR) in Patients With Advanced Upper Lobe Predominant Emphysema
1 other identifier
interventional
22
1 country
8
Brief Summary
The purpose of this study it to evaluate the efficacy and safety of the 20 mL BLVR System 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 Aug 2007
8 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
August 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 9, 2007
CompletedFirst Posted
Study publicly available on registry
August 13, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedOctober 24, 2011
October 1, 2011
8 months
August 9, 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 post treatment
Secondary Outcomes (6)
Improvement in exercise capacity
12 weeks post treatment
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
- +1 more secondary outcomes
Study Arms (2)
Group 1
EXPERIMENTALTreatment will be administered in 2 treatment sessions.
Group 2
EXPERIMENTALTreatment will be administered in a single treatment session.
Interventions
Eligibility Criteria
You may qualify if:
- clinical diagnosis of advanced upper lobe 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)
- Minute Walk Distance \>/= 150 m
You may not qualify if:
- alpha-1 protease inhibitor deficiency
- homogeneous emphysema
- 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
- inability to tolerate bronchoscopy under conscious sedation (or anesthesia)
- history of renal infarction or renal failure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Pulmonary Associates
Phoenix, Arizona, 85006, United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa, 52242, United States
Veritas Clinical Specialties, Ltd
Topeka, Kansas, 66606, United States
St Joseph's Medical Center
Towson, Maryland, 21204, United States
Akron Medical Center
Akron, Ohio, 44302, United States
Pulmonary, Allergy & Critical Care Medicine, Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Temple University Lung Center
Philadelphia, Pennsylvania, 19140, United States
Medical University of South Carolina
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
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Geoffrey McLennan, MD
University of Iowa Hospitals & Clinics, Iowa City, IA
- PRINCIPAL INVESTIGATOR
Charlie Strange, MD
Medical University of South Carolina
- PRINCIPAL INVESTIGATOR
Mark Gotfried, MD
Pulmonary Associates, Phoenix, AZ
- PRINCIPAL INVESTIGATOR
Mark Krasna, MD
St Joseph's Medical Center, Towson, MD
- PRINCIPAL INVESTIGATOR
Sanjiv Tewari, MD
Akron Medical Center, Akron, OH
- PRINCIPAL INVESTIGATOR
Gerard Criner, MD
Temple University Lung Center, Philadelphia, PA
- PRINCIPAL INVESTIGATOR
William Leeds, DO
Veritas Clinical Specialties, Topeka, KS
- PRINCIPAL INVESTIGATOR
Thomas Gildea, MD
Pulmonary, Allergy & Critical Care Medicine, Cleveland Clinic, Cleveland, OH
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
August 9, 2007
First Posted
August 13, 2007
Study Start
August 1, 2007
Primary Completion
April 1, 2008
Study Completion
December 1, 2009
Last Updated
October 24, 2011
Record last verified: 2011-10