TABLE 3

FEV1 AUC0–3 and trough FEV1 responses (i.e. change from baseline) after 24 weeks of treatment by ICS usage (full analysis set, combined data)

Treatment comparisonICS usage
YesNo
Adjusted mean±se (95% CI)p-valueAdjusted mean±se (95% CI)p-value
FEV1 AUC0–3 L
 Common study baseline1.073±0.0091.226±0.010
 Tiotropium+olodaterol 5/5 µg
  versus olodaterol 5 µg0.131±0.012 (0.107–0.154)<0.00010.125±0.012 (0.101–0.148<0.0001
  versus tiotropium 5 µg0.113±0.012 (0.089–0.137)<0.00010.108±0.012 (0.085–0.132)<0.0001
 Tiotropium+olodaterol 2.5/5 µg
  versus olodaterol 5 µg0.117±0.012 (0.093–0.141)<0.00010.113±0.012 (0.090–0.137)<0.0001
  versus tiotropium 2.5 µg0.104±0.012 (0.080–0.128)<0.00010.120±0.012 (0.096–0.143)<0.0001
  versus tiotropium 5 µg0.099±0.012 (0.075–0.123)<0.00010.097±0.012 (0.074–0.120)<0.0001
 Tiotropium+olodaterol 5/5 µg
  versus tiotropium+olodaterol 2.5/5 µg0.014±0.012 (–0.010–0.037)0.25330.012±0.012 (–0.012–0.035)0.3342
Trough FEV1 L
 Common study baseline1.075±0.0091.227±0.010
 Tiotropium+olodaterol 5/5 µg
  versus olodaterol 5 µg0.087±0.012 (0.063–0.111)<0.00010.082±0.013 (0.057–0.107)<0.0001
  versus tiotropium 5 µg0.045±0.012 (0.021–0.070)0.00030.076±0.012 (0.052–0.100)<0.0001
 Tiotropium+olodaterol 2.5/5 µg
  versus olodaterol 5 µg0.068±0.012 (0.044–0.092)<0.00010.056±0.013 (0.031–0.080)<0.0001
  versus tiotropium 2.5 µg0.030±0.012 (0.006–0.055)0.01550.060±0.012 (0.036–0.084)<0.0001
  versus tiotropium 5 µg0.026±0.013 (0.001–0.050)0.03850.050±0.012 (0.025–0.074)<0.0001
 Tiotropium+olodaterol 5/5 µg
  versus tiotropium+olodaterol 2.5/5 µg0.019±0.012 (−0.005–0.043)0.11340.026±0.013 (0.002–0.051)0.0369
  • FEV1: forced expiratory volume in 1 s; AUC0–3: area under the curve from 0 to 3 h; ICS: inhaled corticosteroid.