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Sponsored by: |
Aeris Therapeutics |
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Information provided by: | Aeris Therapeutics |
ClinicalTrials.gov Identifier: | NCT00716053 |
The purpose of the study is to evaluate the efficacy and safety of the 20 mL BLVR System in treating patients with advanced upper lobe predominant emphysema.
Condition | Intervention | Phase |
---|---|---|
Advanced Upper Lobe Predominant Emphysema |
Drug: Biologic Lung Volume Reduction (Hydrogel) Drug: Biologic Lung Volume Reduction Sham |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase 3 Study of the Biologic Lung Volume Reduction (BLVR) System in Patients With Advanced Upper Lobe Predominant Emphysema |
Estimated Enrollment: | 225 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | September 2011 |
Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
treatment: Experimental
BLVR treatment
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Drug: Biologic Lung Volume Reduction (Hydrogel)
20 mL BLVR Hydrogel
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control: Sham Comparator
sham BLVR
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Drug: Biologic Lung Volume Reduction Sham
20 mL Saline
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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 to achieve lung volume reduction without surgery and its attendant risks. With BLVR, a physician uses a bronchoscope to direct treatment to the most damaged areas of the patient's lungs. The treatment delivers a precisely proportioned proprietary mixture of drugs and biologics which, when combined at the treatment site, form a bioabsorbable gel. The gel is comprised of clotting proteins that deliver the treatment, an antibiotic to prevent infection and drugs designed to remodel damaged areas of the lungs—actually using the body's natural scar formation response to permanently collapse the diseased areas. This reduction in lung volume creates more space for adjacent healthier parts of the lungs to function more effectively.
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Whitney Kent, MBA, CCRP | 781-904-2350 | whitney.kent@aerist.com |
United States, Alabama | |
University of Alabama | |
Birmingham, Alabama, United States | |
United States, Arizona | |
Pulmonary Associates | |
Phoenix, Arizona, United States | |
United States, Iowa | |
Internal Med, Univ of Iowa Hospitals & Clinics | |
Iowa City, Iowa, United States | |
United States, Kansas | |
Veritas Clinical Specialties | |
Topeka, Kansas, United States | |
United States, Massachusetts | |
Caritas St Elizabeth's Medical Center | |
Boston, Massachusetts, United States | |
United States, Ohio | |
Pulmonary Allergy & Crit Care Med, Cleveland Clinic Foundation | |
Cleveland, Ohio, United States | |
United States, Pennsylvania | |
Temple University Lung Center | |
Philadelphia, Pennsylvania, United States | |
United States, South Carolina | |
Div Pulmonary Med, Med Univ of South Carolina | |
Charleston, South Carolina, United States | |
Israel | |
Rabin Medical Center | |
Petach Tikva, Israel |
Study Chair: | Edward P Ingenito, MD, PhD | Aeris Therapeutics, Inc |
Responsible Party: | Aeris Therapeutics, Inc ( Edward Ingenito, MD, PhD ) |
Study ID Numbers: | 01-C08-001 |
Study First Received: | July 15, 2008 |
Last Updated: | December 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00716053 |
Health Authority: | United States: Food and Drug Administration |
emphysema chronic obstructive pulmonary disease COPD lung volume reduction |
LVRS BLVR Aeris |
Pulmonary Emphysema Emphysema Lung Diseases, Obstructive |
Respiratory Tract Diseases Lung Diseases Pulmonary Disease, Chronic Obstructive |
Pathologic Processes |