Table 1.
Co-primary efficacy endpoints | Mean % change in FEV1 and 6 MWT in the treatment group as compared to control group at 180 days post randomization. |
Primary safety endpoint | Major Complications Composite at 180 days post randomization. |
Secondary efficacy endpoints | Mean absolute change in: - St. George's Respiratory Questionnaire - Maximal work load as measured by cycle ergometry - Daily oxygen requirement - mMRC |
Secondary safety endpoints | Complications (type, timing, and severity, including Kaplan-Meier survival analysis) Device-related adverse events during procedure hospitalization Device-related adverse events post discharge |
Abbreviations: FEV1 = forced expiratory volume in one second, 6 MWT = six minute walk test, RV = residual volume, DLco = diffusion of the lung for carbon dioxide, BODE index = body-mass index, airflow obstruction, dyspnea, and exercise capacity index, EBV = endobronchial valve, mMRC = modified Medical Research Council dyspnea scale