title: 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.affiliation: Division of Cardiothoracic Surgery, Rabin Medical Center, Tel Aviv, Israel. Yaelre2@clalit.org
authors.forename: Y
authors.initials: Y
authors.lastname: Refaely
authors.forename: M
authors.initials: M
authors.lastname: Dransfield
authors.forename: M R
authors.initials: MR
authors.lastname: Kramer
authors.forename: M
authors.initials: M
authors.lastname: Gotfried
authors.forename: W
authors.initials: W
authors.lastname: Leeds
authors.forename: G
authors.initials: G
authors.lastname: McLennan
authors.forename: S
authors.initials: S
authors.lastname: Tewari
authors.forename: M
authors.initials: M
authors.lastname: Krasna
authors.forename: G J
authors.initials: GJ
authors.lastname: Criner
mesh_terms: D000368:Aged; D001691:Biological Therapy; D001999:Bronchoscopy / Q000379:methods*; D004417:Dyspnea / Q000601:surgery / Q000628:therapy; D015444:Exercise; D005260:Female; D015718:Fibrin Tissue Adhesive / Q000627:therapeutic use*; D005500:Follow-Up Studies; D005541:Forced Expiratory Volume; D006801:Humans; D008297:Male; D008875:Middle Aged; D011013:Pneumonectomy / Q000379:methods*; D011656:Pulmonary Emphysema / Q000188:drug therapy / Q000601:surgery / Q000628:therapy*; D011788:Quality of Life; D016896:Treatment Outcome; D014797:Vital Capacity
chemical_list: D015718:Fibrin Tissue Adhesive