• Eur. Respir. J. · Sep 2015

    Randomized Controlled Trial Comparative Study

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

    • Carolyn E Come, Mordechai R Kramer, Mark T Dransfield, Muhanned Abu-Hijleh, David Berkowitz, Michela Bezzi, Surya P Bhatt, Michael B Boyd, Enrique Cases, Alexander C Chen, Christopher B Cooper, Javier Flandes, Thomas Gildea, Mark Gotfried, D Kyle Hogarth, Kumaran Kolandaivelu, William Leeds, Timothy Liesching, Nathaniel Marchetti, Charles Marquette, Richard A Mularski, Victor M Pinto-Plata, Michael A Pritchett, Samaan Rafeq, Edmundo R Rubio, Dirk-Jan Slebos, Grigoris Stratakos, Alexander Sy, Larry W Tsai, Momen Wahidi, John Walsh, J Michael Wells, Patrick E Whitten, Roger Yusen, Javier J Zulueta, Gerard J Criner, and George R Washko.
    • For a full list of the authors' affiliations please see the Acknowledgements ccome@partners.org.
    • Eur. Respir. J. 2015 Sep 1; 46 (3): 651-62.

    AbstractUncontrolled 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.Copyright ©ERS 2015.

      Pubmed     Full text   Copy Citation     Plaintext  

      Add institutional full text...

    Notes

     
    Knowledge, pearl, summary or comment to share?
    300 characters remaining
    help        
    You can also include formatting, links, images and footnotes in your notes
    • Simple formatting can be added to notes, such as *italics*, _underline_ or **bold**.
    • Superscript can be denoted by <sup>text</sup> and subscript <sub>text</sub>.
    • Numbered or bulleted lists can be created using either numbered lines 1. 2. 3., hyphens - or asterisks *.
    • Links can be included with: [my link to pubmed](http://pubmed.com)
    • Images can be included with: ![alt text](https://bestmedicaljournal.com/study_graph.jpg "Image Title Text")
    • For footnotes use [^1](This is a footnote.) inline.
    • Or use an inline reference [^1] to refer to a longer footnote elseweher in the document [^1]: This is a long footnote..

    hide…