Homogeneous Emphysema Clinical Trial
Official title:
Phase 2 Study of the 20 mL Biologic Lung Volume Reduction (BLVR) System in Patients With Homogeneous or Upper Lobe Predominant Emphysema
The purpose of the study is to evaluate the efficacy and safety of the 20 mL BLVR System in patients with homogeneous emphysema. Patients with upper lobe predominant emphysema initially screened for earlier Phase 2 studies but not enrolled before study enrollment closed are also eligible for participation.
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 (LVRS) involves the removal of diseased portions of the lung
in order to enable the remaining, healthier portions of the lung to function better. LVRS,
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
or in the case of homogeneous disease, areas that are less active as shown by the extent of
regional blood flow. 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
treated areas of the lung. This provides room within the chest to allow the remaining
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 (upper lobe
predominant) 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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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment