Table 2 EASE Trial Exclusion Criteria

Pulmonary Function

Change in FEV₁ > 20% between pre-and post-bronchodilator measurements or >200 mL if the subject's post-bronchodilator FEV₁ < 1 liter

Clinically significant bronchiectasis

Three or more respiratory infections requiring hospitalization in the last 12 months

Respiratory infection <30 days prior to randomization

Presence of segmental atelectasis, lobar consolidation, significant or unstable pulmonary infiltrate or pneumothorax confirmed on x-ray

DLco <15% of predicted

Arterial blood gas analysis

Values on room air, pH <7.35 with a PaCO₂ > 50 mmHg or PaCO₂ > 60 mmHg regardless of pH

Physical

BMI >31.1 for males and >32.3 for females

Unplanned weight loss >10% usual weight in 90 days prior to randomization

General Medical

Uncontrolled hypertension (systolic >200 mmHg or diastolic >110 mmHg)

Stroke within last 12 months

Suspicion or history of pulmonary hypertension, defined by either of the following: Abnormal Radionuclide Ventriculogram/Echocardiogram showing Right Ventricular Ejection Fraction <30%; or evidence of right ventricular dilatation; or evidence of hypokinesia; or RVSP >45 mmHg

Myocardial infarction within 6 months

Type 1 diabetes

Current diagnosis of renal failure

Lung cancer or pulmonary nodule requiring surgery

Ventilator dependence

Previous lung volume reduction surgery or lobectomy

Known hypersensitivity to aspirin, paclitaxel or stainless steel