Table 1 EASE Trial Inclusion Criteria
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 |