Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Phase 2 Study of the 20 mL Biologic Lung Volume Reduction System (BLVR) in Patients With Advanced Upper Lobe Predominant Emphysema
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.
Background:
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.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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