A randomised trial of lung sealant versus medical therapy for advanced emphysema.

Published

Journal Article

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.

Full Text

Duke Authors

Cited Authors

  • Come, CE; Kramer, MR; Dransfield, MT; Abu-Hijleh, M; Berkowitz, D; Bezzi, M; Bhatt, SP; Boyd, MB; Cases, E; Chen, AC; Cooper, CB; Flandes, J; Gildea, T; Gotfried, M; Hogarth, DK; Kolandaivelu, K; Leeds, W; Liesching, T; Marchetti, N; Marquette, C; Mularski, RA; Pinto-Plata, VM; Pritchett, MA; Rafeq, S; Rubio, ER; Slebos, D-J; Stratakos, G; Sy, A; Tsai, LW; Wahidi, M; Walsh, J; Wells, JM; Whitten, PE; Yusen, R; Zulueta, JJ; Criner, GJ; Washko, GR

Published Date

  • September 2015

Published In

Volume / Issue

  • 46 / 3

Start / End Page

  • 651 - 662

PubMed ID

  • 25837041

Pubmed Central ID

  • 25837041

Electronic International Standard Serial Number (EISSN)

  • 1399-3003

Digital Object Identifier (DOI)

  • 10.1183/09031936.00205614

Language

  • eng

Conference Location

  • England