TABLE 2

FEV1 AUC0–3 and trough FEV1 responses (i.e. change from baseline) after 24 weeks of treatment (full analysis set) in Studies 1237.5 and 1237.6 separately

Treatment comparisonFEV1 AUC0–3# Lp-valueTrough FEV1 Lp-value
Study 1237.5 common study baseline1.158±0.0101.161±0.010
 Tiotropium+olodaterol 5/5 µg
  versus olodaterol 5 µg0.123±0.012 (0.100–0.146)<0.00010.082±0.012 (0.059–0.106)<0.0001
  versus tiotropium 5 µg0.117±0.012 (0.094–0.140)<0.00010.071±0.012 (0.047–0.094)<0.0001
 Tiotropium+olodaterol 2.5/5 µg
  versus olodaterol 5 µg0.109±0.012 (0.086–0.132)<0.00010.058±0.012 (0.034–0.081)<0.0001
  versus tiotropium 2.5 µg0.093±0.012 (0.070–0.116)<0.00010.029±0.012 (0.005–0.052)0.0174
  versus tiotropium 5 µg0.102±0.012 (0.080–0.125)<0.00010.046±0.012 (0.023–0.070)0.0001
 Tiotropium+olodaterol 5/5 µg
  versus tiotropium+olodaterol 2.5/5 µg0.014±0.012 (-0.008–0.037)0.21690.024±0.012 (0.001–0.048)0.0407
Study 1237.6 common study baseline1.150±0.0101.150±0.010
 Tiotropium+olodaterol 5/5 µg
  versus olodaterol 5 µg0.132±0.013 (0.108–0.157)<0.00010.088±0.013 (0.063–0.113)<0.0001
  versus tiotropium 5 µg0.103±0.012 (0.078–0.127)<0.00010.050±0.013 (0.024–0.075)0.0001
 Tiotropium+olodaterol 2.5/5 µg
  versus olodaterol 5 µg0.121±0.012 (0.096–0.145)<0.00010.067±0.013 (0.042–0.092)<0.0001
  versus tiotropium 2.5 µg0.131±0.012 (0.106–0.155)<0.00010.062±0.013 (0.037–0.087)<0.0001
  versus tiotropium 5 µg0.091±0.012 (0.066–0.115)<0.00010.029±0.013 (0.004–0.054)0.0231
 Tiotropium+olodaterol 5/5 µg
  versus tiotropium+olodaterol 2.5/5 µg0.012±0.012 (-0.013–0.036)0.33940.021±0.013 (-0.004–0.046)0.1073
  • Data are presented as adjusted mean±se (95% CI), unless otherwise stated. Adjusted means were obtained from fitting a mixed model for repeated measurements, including fixed effects of treatment, planned test day, treatment-by-test-day interaction, baseline and baseline-by-test-day interaction; patient as a random effect; spatial power covariance structure for within-patient errors and Kenward−Roger approximation of denominator degrees of freedom. FEV1: forced expiratory volume in 1 s; AUC0–3: area under the curve from 0 to 3 h. #: number of patients contributing to the mixed model for repeated measurements for adjusted mean FEV1 AUC0–3 Study 1237.5: tiotropium+olodaterol 5/5 μg n=522, tiotropium+olodaterol 2.5/5 μg n=521, tiotropium 5 μg n=526, tiotropium 2.5 μg n=524, olodaterol 5 μg n=525; Study 1237.6: tiotropium+olodaterol 5/5 μg n=502, tiotropium+olodaterol 2.5/5 μg n=506, tiotropium 5 μg n=500, tiotropium 2.5 μg n=504, olodaterol 5 μg n=507. : number of patients contributing to the mixed model for repeated measurements for adjusted mean trough FEV1 Study 1237.5: tiotropium+olodaterol 5/5 μg n=521, tiotropium+olodaterol 2.5/5 μg n=518, tiotropium 5 μg n=520, tiotropium 2.5 μg n=519, olodaterol 5 μg n=519; Study 1237.6: tiotropium+olodaterol 5/5 μg n=497, tiotropium+olodaterol 2.5/5 μg n=500, tiotropium 5 μg n=498, tiotropium 2.5 μg n=499, olodaterol 5 μg n=503.