Biologic lung volume reduction therapy for advanced homogeneous emphysema.

Abstract

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.

• Authors: Y Refaely, M Dransfield, M R Kramer, M Gotfried, W Leeds, G McLennan, S Tewari, M Krasna, G J Criner
• Journal: The European respiratory journal (Eur Respir J) Vol. 36 Issue 1 Pg. 20-7 (Jul 2010) ISSN: 1399-3003 [Electronic] England
• PMID: 19926742 (Publication Type: Clinical Trial, Phase II, Journal Article)

Chemical References

• Fibrin Tissue Adhesive

Topics

• Aged
• Biological Therapy
• Bronchoscopy (methods)
• Dyspnea (surgery, therapy)
• Exercise
• Female
• Fibrin Tissue Adhesive (therapeutic use)
• Follow-Up Studies
• Forced Expiratory Volume
• Humans
• Male
• Middle Aged
• Pneumonectomy (methods)
• Pulmonary Emphysema (drug therapy, surgery, therapy)
• Quality of Life
• Treatment Outcome
• Vital Capacity