Document Detail

Biologic lung volume reduction therapy for advanced homogeneous emphysema.
MedLine Citation:
PMID:  19926742     Owner:  NLM     Status:  MEDLINE    
This report summarises phase 2 trial results of biologic lung volume reduction (BioLVR) for treatment of advanced homogeneous emphysema. BioLVR therapy was administered bronchoscopically to 25 patients with homogeneous emphysema in an open-labelled study. Eight patients received low dose (LD) treatment with 10 mL per site at eight subsegments; 17 received high dose (HD) treatment with 20 mL per site at eight subsegments. Safety was assessed in terms of medical complications during 6-month follow-up. Efficacy was assessed in terms of change from baseline in gas trapping, spirometry, diffusing capacity, exercise capacity, dyspnoea and health-related quality of life. There were no deaths or serious medical complications during the study. A statistically significant reduction in gas trapping was observed at 3-month follow-up among HD patients, but not LD patients. At 6 months, changes from baseline in forced expiratory volume in 1 s (-8.0+/-13.93% versus +13.8+/-20.26%), forced vital capacity (-3.9+/-9.41% versus +9.0+/-13.01%), residual volume/total lung capacity ratio (-1.4+/-13.82% versus -5.4+/-12.14%), dyspnoea scores (-0.4+/-1.27 versus -0.8+/-0.73 units) and St George's Respiratory Questionnaire total domain scores (-4.9+/-8.3 U versus -12.2+/-12.38 units) were better with HD than with LD therapy. BioLVR therapy with 20 mL per site at eight subsegmental sites may be a safe and effective therapy in patients with advanced homogeneous emphysema.
Y Refaely; M Dransfield; M R Kramer; M Gotfried; W Leeds; G McLennan; S Tewari; M Krasna; G J Criner
Publication Detail:
Type:  Clinical Trial, Phase II; Journal Article     Date:  2009-11-19
Journal Detail:
Title:  The European respiratory journal     Volume:  36     ISSN:  1399-3003     ISO Abbreviation:  Eur. Respir. J.     Publication Date:  2010 Jul 
Date Detail:
Created Date:  2010-07-02     Completed Date:  2010-10-21     Revised Date:  2013-05-23    
Medline Journal Info:
Nlm Unique ID:  8803460     Medline TA:  Eur Respir J     Country:  Switzerland    
Other Details:
Languages:  eng     Pagination:  20-7     Citation Subset:  IM    
Division of Cardiothoracic Surgery, Rabin Medical Center, Tel Aviv, Israel.
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MeSH Terms
Biological Therapy
Bronchoscopy / methods*
Dyspnea / surgery,  therapy
Fibrin Tissue Adhesive / therapeutic use*
Follow-Up Studies
Forced Expiratory Volume
Middle Aged
Pneumonectomy / methods*
Pulmonary Emphysema / drug therapy,  surgery,  therapy*
Quality of Life
Treatment Outcome
Vital Capacity
Reg. No./Substance:
0/Fibrin Tissue Adhesive
Comment In:
Eur Respir J. 2010 Jul;36(1):8-9   [PMID:  20595161 ]

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