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Open Access Highly Accessed Study protocol

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

Pallav L Shah1*, Dirk-Jan Slebos2, Paulo FG Cardoso3, Edward J Cetti1, Gerhard W Sybrecht4 and Joel D Cooper5

Author Affiliations

1 Royal Brompton Hospital, Sydney Street, London SW3 6NP, UK, and Imperial College London, UK

2 University Medical Center Groningen, 9700 RB Groningen, The Netherlands

3 Heart Institute (InCor)-Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Rua Dr.Eneas de Carvalho Aguiar 44, 2 andar, bloco 2, sala 9, São Paulo-SP, Brazil

4 Klinik fur Innere Medizin, Pneumologie, Allergologie, Beatmungs- und Umweltmedizin, Universitätsklinikum des Saarlandes, Germany

5 Hospital of the University of Pennsylvania, 3400 Spruce St, Philadelphia, PA, 19104, USA

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BMC Pulmonary Medicine 2011, 11:1  doi:10.1186/1471-2466-11-1

Published: 7 January 2011

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 webcite 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 FEV1/FVC < 70%, FEV1≤50% of predicted or FEV1 < 1 liter, RV/TLC≥0.65 at screening, marked dyspnea score ≥2 on the modified Medical Research Council scale of 0-4, a smoking history of at least 20 pack years and stopped smoking for at least 8 weeks prior to enrollment. Following 16 to 20 supervised pulmonary rehabilitation sessions, subjects were randomized 2:1 to receive either a treatment (Exhale® Drug-Eluting Stent) or a sham bronchoscopy. A responder analysis will evaluate the co-primary endpoints of an FVC improvement ≥12% of the patient baseline value and modified Medical Research Council dyspnea scale improvement (reduction) ≥1 point at the 6-month follow-up visit.

Discussion

If through the EASE Trial, Airway Bypass is shown to improve pulmonary function and reduce dyspnea while demonstrating an acceptable safety profile, then homogeneous patients will have a minimally invasive treatment option with meaningful clinical benefit.

Trial Registration

ClinicalTrials.gov: NCT00391612