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Biologic lung volume reduction in advanced upper lobe emphysema: phase 2 results
Gerard J Criner1, Victor Pinto-Plata, Charlie Strange
1Temple Lung Center, Temple University School of Medicine, 745 Parkinson Pavilion, 3401 North Broad Street, Philadelphia, PA 19140. crinerg@tuhs.temple.edu
American Journal of Respiratory and Critical Care Medicine
|January 31, 2009
Summary
Biologic lung volume reduction (BioLVR) offers a safe and effective treatment for advanced emphysema, improving lung function and quality of life. Higher doses of BioLVR hydrogel showed more durable and significant patient benefits.
Area of Science:
- Pulmonary Medicine
- Regenerative Medicine
- Interventional Pulmonology
Background:
- Advanced emphysema significantly impacts lung function and quality of life.
- Biologic lung volume reduction (BioLVR) is an emerging endobronchial therapy utilizing tissue remodeling to decrease lung volume.
- Current treatment options for emphysema have limitations, necessitating novel therapeutic approaches.
Purpose of the Study:
- To evaluate the safety and determine the optimal therapeutic dose of BioLVR hydrogel for patients with upper lobe predominant emphysema.
- To assess the efficacy of BioLVR hydrogel in improving physiological and functional outcomes in this patient population.
Main Methods:
- Phase 2, open-label, multicenter, dose-ranging studies were conducted.
- BioLVR hydrogel was administered to eight subsegmental sites (four per upper lobe) at either a low dose (LD, 10 ml/site) or high dose (HD, 20 ml/site).
- Safety was monitored via serious medical complications, while efficacy was measured by changes in pulmonary function tests, dyspnea scores, 6-minute walk distance, and quality of life.
Main Results:
- No deaths occurred; four serious treatment-related complications were reported.
- Both LD and HD treatments resulted in a significant reduction in the residual volume to total lung capacity ratio at 12 weeks.
- The high-dose group demonstrated significantly greater improvements in FEV1 and FVC at 6 months compared to the low-dose group, with both groups showing improved symptom scores and quality of life.
Conclusions:
- BioLVR hydrogel demonstrates an acceptable safety profile and improves physiological and functional outcomes in patients with upper lobe predominant emphysema up to 6 months post-treatment.
- The high-dose (20 ml/site) BioLVR treatment led to greater and more durable improvements compared to the low-dose (10 ml/site) regimen.
- BioLVR represents a promising therapeutic option for managing advanced emphysema.
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