Felix J F Herth1, Dirk-Jan Slebos2,3, Pallav L Shah4,5, Martin Hetzel6, Gerald Schmid-Bindert7,8, Adam S LaPrad9, Gaëtan Deslée10, Arschang Valipour11. 1. Thoraxklinik and Translational Lung Research Center (TLRC), University of Heidelberg, Heidelberg, Germany. 2. Department of Pulmonary Diseases, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands. 3. Groningen Research Institute for Asthma and COPD, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands. 4. Royal Brompton Hospital and Chelsea and Westminster Hospital, London, United Kingdom. 5. National Heart and Lung Institute, Imperial College, London, United Kingdom. 6. Krankenhaus vom Roten Kreuz, Stuttgart, Germany. 7. PneumRx GmbH, a BTG International Group Company, Mannheim, Germany. 8. Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany. 9. PneumRx, Inc., a BTG International Group Company, Santa Clara, California, USA. 10. University Hospital of Reims, INSERM U1250, Reims, France. 11. Karl-Landsteiner-Institute for Lung Research and Pulmonary Oncology, Department of Respiratory and Critical Care Medicine, Krankenhaus Nord-Klinik Floridsdorf, Vienna, Austria, arschang.valipour@wienkav.at.
Abstract
BACKGROUND: The PneumRx endobronchial coil system for patients with severe emphysema has been shown to improve quality of life, exercise capacity, and pulmonary function in patients with emphysema. A post hoc analysis of the RENEW trial has identified patient characteristics and lobar selection methods associated with improved outcomes, which have to be confirmed prospectively. METHODS: The ELEVATE trial is a prospective, multicenter, open label, randomized (2:1), controlled trial comparing outcomes in patients treated with endobronchial coils (treatment) to a medically managed control group (control). The trial aims to enroll 210 patients (140 in the treatment group and 70 in the control group) with severe emphysema. Control patients will be eligible to crossover to coil treatment after 6 months of follow-up. The co-primary effectiveness endpoints are percent change in forced expiratory volume in 1 s and quality of life measured by change in St. George's Respiratory Questionnaire from baseline to 6 months. Secondary objectives are determination of responder rates of clinical endpoints and mean change in other functional and physiologic endpoints. All patients will be followed for 24 months after initial treatment. Adverse events will be collected on an ongoing basis throughout the trial. DISCUSSION: The primary objective of the ELEVATE trial is to prospectively confirm the safety and effectiveness profile of the coil system for the treatment of severe emphysema in consideration of the findings of previous randomized controlled trials. Secondary objectives are the determination of responder rates in all clinical endpoints and mean change in physiologic endpoints.
RCT Entities:
BACKGROUND: The PneumRx endobronchial coil system for patients with severe emphysema has been shown to improve quality of life, exercise capacity, and pulmonary function in patients with emphysema. A post hoc analysis of the RENEW trial has identified patient characteristics and lobar selection methods associated with improved outcomes, which have to be confirmed prospectively. METHODS: The ELEVATE trial is a prospective, multicenter, open label, randomized (2:1), controlled trial comparing outcomes in patients treated with endobronchial coils (treatment) to a medically managed control group (control). The trial aims to enroll 210 patients (140 in the treatment group and 70 in the control group) with severe emphysema. Control patients will be eligible to crossover to coil treatment after 6 months of follow-up. The co-primary effectiveness endpoints are percent change in forced expiratory volume in 1 s and quality of life measured by change in St. George's Respiratory Questionnaire from baseline to 6 months. Secondary objectives are determination of responder rates of clinical endpoints and mean change in other functional and physiologic endpoints. All patients will be followed for 24 months after initial treatment. Adverse events will be collected on an ongoing basis throughout the trial. DISCUSSION: The primary objective of the ELEVATE trial is to prospectively confirm the safety and effectiveness profile of the coil system for the treatment of severe emphysema in consideration of the findings of previous randomized controlled trials. Secondary objectives are the determination of responder rates in all clinical endpoints and mean change in physiologic endpoints.
Authors: Karin Klooster; Nick H T Ten Hacken; Ina Franz; Huib A M Kerstjens; Eva M van Rikxoort; Dirk-Jan Slebos Journal: Respiration Date: 2014-05-28 Impact factor: 3.580
Authors: Dirk-Jan Slebos; Jorine E Hartman; Karin Klooster; Stefan Blaas; Gaetan Deslee; Wolfgang Gesierich; Juergen Hetzel; Martin Hetzel; William McNulty; Samuel V Kemp; Romain Kessler; Sylvie Leroy; Franz Stanzel; Christian Witt; Zaid Zoumot; Felix J F Herth; Pallav L Shah Journal: Respiration Date: 2015-06-25 Impact factor: 3.580
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