A Phase 1 interventional study of Biologic Lung Volume Reduction (BLVR) - 10 mL Hydrogel in Pulmonary Emphysema and Chronic Obstructive Pulmonary Disease, sponsored by Aeris Therapeutics. Completed at 1 site in Israel. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2010-01-18.
Sponsored by Aeris Therapeutics · Phase 1, Interventional, and Treatment
The purpose of this study is to evaluate the safety and efficacy of the Biologic Lung Volume Reduction System (BLVR) for patients with advanced emphysema refractory to medical therapy.
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.
2,592 studies on the registry are indexed under Lung Diseases, Obstructive; 198 are open to participants now.
This study's enrollment of 16 is below the median of 66 across 1,837 interventional studies indexed under Lung Diseases, Obstructive.
Browse Lung Diseases, Obstructive 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:
Treatment will be administered in two sessions.
Drug: Biologic Lung Volume Reduction (BLVR) - 10 mL Hydrogel
Treatment will be administered in a single session.
Drug: Biologic Lung Volume Reduction (BLVR) - 10 mL Hydrogel
10 mL Hydrogel
SAEs - Safety of treatment and the procedure
Time frame: 1 year
Reduction in gas trapping
Time frame: 12 weeks
Improvement in exercise capacity
Time frame: 12 weeks
Improvement in lung function (vital capacity)
Time frame: 12 weeks
Improvement in lung function (expiratory flow)
Time frame: 12 weeks
Improvement on dyspnea symptoms
Time frame: 12 weeks
Improvement in quality of life
Time frame: 12 weeks
This study is completed, as verified in Jan 2010. You cannot join it, but the record below documents what was studied.
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Aeris Therapeutics