title: A randomised trial of lung sealant versus medical therapy for advanced emphysema.
abstract: Uncontrolled pilot studies demonstrated promising results of endoscopic lung volume reduction using emphysematous lung sealant (ELS) in patients with advanced, upper lobe predominant emphysema. We aimed to evaluate the safety and efficacy of ELS in a randomised controlled setting.Patients were randomised to ELS plus medical treatment or medical treatment alone. Despite early termination for business reasons and inability to assess the primary 12-month end-point, 95 out of 300 patients were successfully randomised, providing sufficient data for 3- and 6-month analysis.57 patients (34 treatment and 23 control) had efficacy results at 3 months; 34 (21 treatment and 13 control) at 6 months. In the treatment group, 3-month lung function, dyspnoea, and quality of life improved significantly from baseline when compared to control. Improvements persisted at 6 months with >50% of treated patients experiencing clinically important improvements, including some whose lung function improved by >100%. 44% of treated patients experienced adverse events requiring hospitalisation (2.5-fold more than control, p=0.01), with two deaths in the treated cohort. Treatment responders tended to be those experiencing respiratory adverse events.Despite early termination, results show that minimally invasive ELS may be efficacious, yet significant risks (probably inflammatory) limit its current utility.
authors.affiliation: For a full list of the authors' affiliations please see the Acknowledgements ccome@partners.org.
authors.forename: Carolyn E
authors.initials: CE
authors.lastname: Come
authors.affiliation: For a full list of the authors' affiliations please see the Acknowledgements.
authors.forename: Mordechai R
authors.initials: MR
authors.lastname: Kramer
authors.affiliation: For a full list of the authors' affiliations please see the Acknowledgements.
authors.forename: Mark T
authors.initials: MT
authors.lastname: Dransfield
authors.affiliation: For a full list of the authors' affiliations please see the Acknowledgements.
authors.forename: Muhanned
authors.initials: M
authors.lastname: Abu-Hijleh
authors.affiliation: For a full list of the authors' affiliations please see the Acknowledgements.
authors.forename: David
authors.initials: D
authors.lastname: Berkowitz
authors.affiliation: For a full list of the authors' affiliations please see the Acknowledgements.
authors.forename: Michela
authors.initials: M
authors.lastname: Bezzi
authors.affiliation: For a full list of the authors' affiliations please see the Acknowledgements.
authors.forename: Surya P
authors.initials: SP
authors.lastname: Bhatt
authors.affiliation: For a full list of the authors' affiliations please see the Acknowledgements.
authors.forename: Michael B
authors.initials: MB
authors.lastname: Boyd
authors.affiliation: For a full list of the authors' affiliations please see the Acknowledgements.
authors.forename: Enrique
authors.initials: E
authors.lastname: Cases
authors.affiliation: For a full list of the authors' affiliations please see the Acknowledgements.
authors.forename: Alexander C
authors.initials: AC
authors.lastname: Chen
authors.affiliation: For a full list of the authors' affiliations please see the Acknowledgements.
authors.forename: Christopher B
authors.initials: CB
authors.lastname: Cooper
authors.affiliation: For a full list of the authors' affiliations please see the Acknowledgements.
authors.forename: Javier
authors.initials: J
authors.lastname: Flandes
authors.affiliation: For a full list of the authors' affiliations please see the Acknowledgements.
authors.forename: Thomas
authors.initials: T
authors.lastname: Gildea
authors.affiliation: For a full list of the authors' affiliations please see the Acknowledgements.
authors.forename: Mark
authors.initials: M
authors.lastname: Gotfried
authors.affiliation: For a full list of the authors' affiliations please see the Acknowledgements.
authors.forename: D Kyle
authors.initials: DK
authors.lastname: Hogarth
authors.affiliation: For a full list of the authors' affiliations please see the Acknowledgements.
authors.forename: Kumaran
authors.initials: K
authors.lastname: Kolandaivelu
authors.affiliation: For a full list of the authors' affiliations please see the Acknowledgements.
authors.forename: William
authors.initials: W
authors.lastname: Leeds
authors.affiliation: For a full list of the authors' affiliations please see the Acknowledgements.
authors.forename: Timothy
authors.initials: T
authors.lastname: Liesching
authors.affiliation: For a full list of the authors' affiliations please see the Acknowledgements.
authors.forename: Nathaniel
authors.initials: N
authors.lastname: Marchetti
authors.affiliation: For a full list of the authors' affiliations please see the Acknowledgements.
authors.forename: Charles
authors.initials: C
authors.lastname: Marquette
authors.affiliation: For a full list of the authors' affiliations please see the Acknowledgements.
authors.forename: Richard A
authors.initials: RA
authors.lastname: Mularski
authors.affiliation: For a full list of the authors' affiliations please see the Acknowledgements.
authors.forename: Victor M
authors.initials: VM
authors.lastname: Pinto-Plata
authors.affiliation: For a full list of the authors' affiliations please see the Acknowledgements.
authors.forename: Michael A
authors.initials: MA
authors.lastname: Pritchett
authors.affiliation: For a full list of the authors' affiliations please see the Acknowledgements.
authors.forename: Samaan
authors.initials: S
authors.lastname: Rafeq
authors.affiliation: For a full list of the authors' affiliations please see the Acknowledgements.
authors.forename: Edmundo R
authors.initials: ER
authors.lastname: Rubio
authors.affiliation: For a full list of the authors' affiliations please see the Acknowledgements.
authors.forename: Dirk-Jan
authors.initials: DJ
authors.lastname: Slebos
authors.affiliation: For a full list of the authors' affiliations please see the Acknowledgements.
authors.forename: Grigoris
authors.initials: G
authors.lastname: Stratakos
authors.affiliation: For a full list of the authors' affiliations please see the Acknowledgements.
authors.forename: Alexander
authors.initials: A
authors.lastname: Sy
authors.affiliation: For a full list of the authors' affiliations please see the Acknowledgements.
authors.forename: Larry W
authors.initials: LW
authors.lastname: Tsai
authors.affiliation: For a full list of the authors' affiliations please see the Acknowledgements.
authors.forename: Momen
authors.initials: M
authors.lastname: Wahidi
authors.affiliation: For a full list of the authors' affiliations please see the Acknowledgements.
authors.forename: John
authors.initials: J
authors.lastname: Walsh
authors.affiliation: For a full list of the authors' affiliations please see the Acknowledgements.
authors.forename: J Michael
authors.initials: JM
authors.lastname: Wells
authors.affiliation: For a full list of the authors' affiliations please see the Acknowledgements.
authors.forename: Patrick E
authors.initials: PE
authors.lastname: Whitten
authors.affiliation: For a full list of the authors' affiliations please see the Acknowledgements.
authors.forename: Roger
authors.initials: R
authors.lastname: Yusen
authors.affiliation: For a full list of the authors' affiliations please see the Acknowledgements.
authors.forename: Javier J
authors.initials: JJ
authors.lastname: Zulueta
authors.affiliation: For a full list of the authors' affiliations please see the Acknowledgements.
authors.forename: Gerard J
authors.initials: GJ
authors.lastname: Criner
authors.affiliation: For a full list of the authors' affiliations please see the Acknowledgements.
authors.forename: George R
authors.initials: GR
authors.lastname: Washko
mesh_terms: D000368:Aged; D005260:Female; D015718:Fibrin Tissue Adhesive / Q000627:therapeutic use*; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011013:Pneumonectomy / Q000379:methods*; D011656:Pulmonary Emphysema / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality / Q000601:surgery*; D011788:Quality of Life; D012129:Respiratory Function Tests; D018570:Risk Assessment; D012720:Severity of Illness Index; D015996:Survival Rate; D013997:Time Factors; D014057:Tomography, X-Ray Computed / Q000379:methods; D016896:Treatment Outcome
chemical_list: D015718:Fibrin Tissue Adhesive
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