US Biologic Lung Volume Reduction (BLVR) Phase 2 Emphysema Study
NCT ID: NCT00515164
Last Updated: 2011-10-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
22 participants
INTERVENTIONAL
2007-08-31
2009-12-31
Brief Summary
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Detailed Description
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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 volume reduction surgery has become an accepted therapy for advanced emphysema. Lung volume reduction surgery involves the removal of diseased portions of the lung in order to enable the remaining, healthier portions of the lung to function better. This procedure, although effective for many patients, is complicated and is accompanied by substantial morbidity and mortality risk.
Aeris Therapeutics has developed the Biologic Lung Volume Reduction (BLVR) System which is intended to achieve lung volume reduction without surgery and its attendant risks. Patients are treated using a bronchoscope to direct treatment to the most damaged areas of the lung. The treatment delivers a precisely proportioned proprietary mixture of drugs and biologics which, when combined at the treatment site, form a biodegradable hydrogel. The hydrogel acts to reduce lung volume by permanently collapsing and sealing the diseased areas of the lung. This provides room within the chest to allow the remaining healthier portions of the lung to function better.
Aeris' BLVR development program has been granted Fast Track designation by the U.S. FDA, and is the subject of ongoing clinical trials designed to investigate the safety and efficacy of the BLVR System as a treatment for patients with advanced heterogeneous emphysema. Fast Track designation is reserved for drug and biologic development programs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Group 1
Treatment will be administered in 2 treatment sessions.
Biologic Lung Volume Reduction (BLVR) - 20 mL Hydrogel
20 mL Hydrogel
Group 2
Treatment will be administered in a single treatment session.
Biologic Lung Volume Reduction (BLVR) - 20 mL Hydrogel
20 mL Hydrogel
Interventions
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Biologic Lung Volume Reduction (BLVR) - 20 mL Hydrogel
20 mL Hydrogel
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
ALL
No
Sponsors
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Aeris Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Geoffrey McLennan, MD
Role: PRINCIPAL_INVESTIGATOR
University of Iowa Hospitals & Clinics, Iowa City, IA
Charlie Strange, MD
Role: PRINCIPAL_INVESTIGATOR
Medical University of South Carolina
Mark Gotfried, MD
Role: PRINCIPAL_INVESTIGATOR
Pulmonary Associates, Phoenix, AZ
Mark Krasna, MD
Role: PRINCIPAL_INVESTIGATOR
St Joseph's Medical Center, Towson, MD
Sanjiv Tewari, MD
Role: PRINCIPAL_INVESTIGATOR
Akron Medical Center, Akron, OH
Gerard Criner, MD
Role: PRINCIPAL_INVESTIGATOR
Temple University Lung Center, Philadelphia, PA
William Leeds, DO
Role: PRINCIPAL_INVESTIGATOR
Veritas Clinical Specialties, Topeka, KS
Thomas Gildea, MD
Role: PRINCIPAL_INVESTIGATOR
Pulmonary, Allergy & Critical Care Medicine, Cleveland Clinic, Cleveland, OH
Locations
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Pulmonary Associates
Phoenix, Arizona, United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States
Veritas Clinical Specialties, Ltd
Topeka, Kansas, United States
St Joseph's Medical Center
Towson, Maryland, United States
Akron Medical Center
Akron, Ohio, United States
Pulmonary, Allergy & Critical Care Medicine, Cleveland Clinic Foundation
Cleveland, Ohio, United States
Temple University Lung Center
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Countries
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References
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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.
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. doi: 10.1378/chest.06-1754.
Criner 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.
Other Identifiers
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01-C07-001
Identifier Type: -
Identifier Source: org_study_id