Advanced Upper Lobe Predominant Emphysema Clinical Trial
Official title:
Phase 3 Study of the Biologic Lung Volume Reduction (BLVR) System in Patients With Advanced Upper Lobe Predominant Emphysema
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.
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment