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BioMed Central, BMC Pulmonary Medicine, 1(11), 2011

DOI: 10.1186/1471-2466-11-1

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Design of the exhale airway stents for emphysema (EASE) trial: an endoscopic procedure for reducing hyperinflation

Journal article published in 2011 by Pallav L. Shah ORCID, Dirk-Jan Slebos, Paulo Fg G. Cardoso, Edward J. Cetti, Gerhard W. Sybrecht, Joel D. Cooper
This paper is made freely available by the publisher.
This paper is made freely available by the publisher.

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Abstract

Abstract Background Airway Bypass is a catheter-based, bronchoscopic procedure in which new passageways are created that bypass the collapsed airways, enabling trapped air to exit the lungs. The Exhale Airway Stents for Emphysema (EASE) Trial was designed to investigate whether Exhale ® Drug-Eluting Stents, placed in new passageways in the lungs, can improve pulmonary function and reduce breathlessness in severely hyperinflated, homogeneous emphysema patients (NCT00391612). Methods/Design The multi-center, randomized, double-blind, sham-controlled trial design was posted on http://www.clinicaltrials.gov in October 2006. Because Bayesian statistics are used for the analysis, the proposed enrollment ranged from 225 up to 450 subjects at up to 45 institutions. Inclusion criteria are: high resolution CT scan with evidence of homogeneous emphysema, post-bronchodilator pulmonary function tests showing: a ratio of FEV 1 /FVC