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

DOI: 10.1186/1471-2466-11-1

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Abstract:

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.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.ClinicalTrials.gov: NCT00391612The primary objective of the EASE randomized, double-blind study is to evaluate the safety and effectiveness of the Exhale? Drug-Eluting Stent (Broncus Technologies, Mountain View, CA) in homogeneous emphysema subjects with severe hyperinflation.According to the National Center for Health Statistics, over 3.7 million adults in the United States report being diagnosed with emphysema, a chronic, progressive, irreversible disease of the lungs (1). It is an under-diagnosed and incurable disease often associated with chronic bronchitis and conditions such as pulmonary hypertension and heart failure

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