Table 3.

Study endpoints

Co-primary effectiveness endpoint	Secondary endpoints	Other effectiveness endpoints
Percent change in FEV1 from baseline to 6 months	Responder rate at 6 months defined as percent of subjects that achieve 2 or more of the following MCIDs	Changes in other pulmonary function measures (RV, RV/TLC, FEV1, FEV1/ FVC)
Change in SGRQ from baseline to 6 months	Change from baseline in: 6MWT ≥26 m [13]  SGRQ ≤–4 points [14]  FEV1 ≥10% [15]  RV ≤–350 mL [16] − Change in mean expiratory target lobar volume measured by HRCT (lobar RV) from baseline to 6 months − Change in VC as measured by plethysmography from baseline to 6 months	− Change in exercise capacity (6MWT) − Mean change at 6 months for CAT and EQ5D − Individual MCID responders at 6 months for 6MWT, SGRQ, and FEV1 as defined above − Responder rate at 6 months defined as percent of subjects that achieve FEV1 ≥12% − Responder rate at 6 months defined as percent of subjects that achieve SGRQ ≤–8 points

6MWT, 6-min walking test; CAT, COPD assessment test; EQ-5D, EuroQol-5 dimensions quality of life questionnaire; FEV_1, forced expiratory volume in 1 s; HRCT, high-resolution CT; lobar RV, mean expiratory lobar volume of the treated lobes calculated via quantitative CT analysis of the expiratory HRCT scans; MCID, minimum clinical important difference; RV, residual volume; SGRQ, St. George's respiratory questionnaire; TLC, total lung capacity; VC, vital capacity.