Pulmonary Function |
Change in FEV1 > 20% between pre-and post-bronchodilator measurements or >200 mL if the subject's post-bronchodilator FEV1 < 1 liter |
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Clinically significant bronchiectasis |
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Three or more respiratory infections requiring hospitalization in the last 12 months |
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Respiratory infection <30 days prior to randomization |
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Presence of segmental atelectasis, lobar consolidation, significant or unstable pulmonary infiltrate or pneumothorax confirmed on x-ray |
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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 |
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Unplanned weight loss >10% usual weight in 90 days prior to randomization |
General Medical |
Uncontrolled hypertension (systolic >200 mmHg or diastolic >110 mmHg) |
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Stroke within last 12 months |
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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 |
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Myocardial infarction within 6 months |
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Type 1 diabetes |
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Current diagnosis of renal failure |
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Lung cancer or pulmonary nodule requiring surgery |
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Ventilator dependence |
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Previous lung volume reduction surgery or lobectomy |
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Known hypersensitivity to aspirin, paclitaxel or stainless steel |