A Phase 2 interventional study of Biologic Lung Volume Reduction in Homogeneous Emphysema, sponsored by Aeris Therapeutics. Completed at 8 sites in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2011-10-24.
Sponsored by Aeris Therapeutics · Phase 2, Interventional, and Treatment
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.
187 studies on the registry are indexed under Pulmonary Emphysema; 19 are open to participants now.
This study's enrollment of 33 is close to the median of 33 across 128 interventional studies indexed under Pulmonary Emphysema.
Browse Pulmonary Emphysema studies →Aeris Therapeutics is the lead sponsor of 17 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
all patients are treated with the experimental therapy
Biological: Biologic Lung Volume Reduction
20 mL Hydrogel
reduction in gas trapping
Time frame: 12 weeks post treatment
improvement in exercise capacity
Time frame: 12 weeks post treatment
improvement in expiratory flow
Time frame: 12 weeks post treatment
improvement in vital capacity
Time frame: 12 weeks post treatment
improvement in dyspnea sysmptoms
Time frame: 12 weeks post treatment
improvemnet in respiratory quality of life
Time frame: 12 weeks post treatment
serious adverse events
Time frame: through 2 years
This study is completed, as verified in Oct 2011. You cannot join it, but the record below documents what was studied.
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Aeris Therapeutics