Skip to main content

Table 1 EASE Trial Inclusion Criteria

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

History and physical Age ≥35 years
  Subject agrees to consult with a cardiologist prior to randomization if findings determine the need for such a consultation
HRCT scan Patient diagnosed by radiology core lab with evidence of homogeneous emphysema with a total score of ≥8
Pulmonary Function Post-bronchodilator ratio of FEV1/FVC <70%
  Post-bronchodilator FEV1 ≤50% of predicted or FEV1 < 1 liter
  Post-bronchodilator RV >180% of predicted
  Post-bronchodilator RV/TLC ≥0.65 at screening
Dyspnea Marked dyspnea, scoring ≥2 on the modified Medical Research Council scale of 0-4, confirmed at the end of pulmonary rehabilitation
Arterial blood gas analysis PaO2 ≥45 mmHg on room air
Rehabilitation Supervised pulmonary rehabilitation of 16-20 sessions over 6-10 weeks prior to the scheduled study procedure
Smoking A smoking history of at least 20 pack-years (1 pack year = 1 pack/day for 1 year) and subject has stopped smoking at least 8 weeks prior to signing the informed consent
Consent Subject has provided written informed consent using a form that has been reviewed and approved by the Institutional Review Board or Ethics Committee
Follow-up Subject is willing to be maintained on standard medical therapy for emphysema for 12 months following the procedure
  Subject is willing and able to return for all required follow-up and supervised pulmonary rehabilitation visits following study enrollment