Sequential Segmental Treatment of Emphysema With Upper Lobe Predominance (STEP-UP) Study

Sequential Segmental Treatment of Emphysema With Upper Lobe Predominance (STEP-UP) Study

This study is designed to demonstrate safety and efficacy in patients with severe upper lobe predominant emphysema. For validity of the study, the results will be compared to patients that receive optimal medical therapy.

Inclusion Criteria:

• Heterogeneous emphysema with upper lobe predominance in both lungs
• FEV1 between 20% and 45% predicted
• Residual volume (RV) > 150% predicted
• Post-rehabilitation 6-minute walk test > 140 meters

Exclusion Criteria:

• More than 3 COPD related hospitalizations requiring antibiotics in past 12 months

• FEV1 < 20% predicted

• DLCO < 20% predicted or immeasurable DLCO

• Body mass index (BMI) < 18kg/m2 or > 32 kg/m2

• History of any of the following:

  • Left ventricular ejection fraction (EF) ≤ 40%
  • Stroke
  • Myocardial infarction or acute coronary syndrome in previous year
  • Hospitalization due to left ventricular failure in previous 3 years