Table 3.
History and physical | Age from 40 to 75 years. BMI ≤ 31.1 kg/m2 (men) or ≤ 32.3 kg/m2 (women). Stable with < 20 mg prednisone (or equivalent) daily. The patient has no child bearing potential OR a negative pregnancy test in a woman of childbearing potential. |
HRCT scan | Patient diagnosed by HRCT Core Lab with eligible heterogeneous emphysema. |
Pulmonary function | FEV1 < 45% of predicted value. TLC > 100% predicted. RV > 150% predicted. |
Blood gas | PaCO2 < 50 mm Hg (Denver < 55 mm Hg). PaO2 > 45 mm Hg (Denver > 30 mm Hg) on room air. |
Exercise | Post rehabilitation 6-minute walk of ≥ 140 meters. |
Smoking | Nonsmoking for 4 months prior to initial interview and throughout screening. Plasma continine level < 13.7 ng/ml (or arterial carboxyhemoglobin < 2.5% if using nicotine products). |
Consent | Patient has provided written informed consent using a form that has been reviewed and approved by the IRB/EC. |
Rehabilitation and follow-up | The patient is willing and able to complete protocol required baseline assessments and procedures. The patient agrees to all protocol required follow-up intervals. |
Abbreviations: BMI = body-mass index, HRCT = high resolution chest computed tomography, FEV1 = forced expiratory volume in one second, TLC = total lung capacity, RV = residual volume, PaO2 = arterial pressure of oxygen, PaCO2 = arterial pressure of carbon dioxide, IRB = institutional review board, EC = Ethics Committee.