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. 2014 Aug 9;3:419. doi: 10.1186/2193-1801-3-419

Table 2.

Adjusted mean FEV 1 AUC 0–12 , AUC 12–24 , and AUC 0–24 responses (L) compared to placebo after 6 weeks

Treatment Adjusted amean (95% CI) difference from placebo at 6 weeks
FEV 1 AUC 0–12 n Adjusted mean (SE) Mean (SE) Pvalue 95% CI
Study 1222.24
  Placebo 93 −0.060 (0.020)
  Olodaterol 5 μg QD 92 0.088 (0.021) 0.148 (0.018) < .0001 0.113, 0.183
  Olodaterol 10 μg QD 91 0.088 (0.021) 0.148 (0.018) < .0001 0.113, 0.183
  Formoterol 12 μg BID 90 0.081 (0.021) 0.141 (0.018) < .0001 0.106, 0.177
Study 1222.25
  Placebo 91 −0.022 (0.024)
  Olodaterol 5 μg QD 92 0.150 (0.024) 0.172 (0.017) < .0001 0.139, 0.205
  Olodaterol 10 μg QD 90 0.152 (0.024) 0.174 (0.017) < .0001 0.140, 0.208
  Formoterol 12 μg BID 90 0.136 (0.024) 0.158 (0.017) < .0001 0.124, 0.191
FEV 1 AUC 12–24
Study 1222.24
  Placebo 93 −0.123 (0.021)
  Olodaterol 5 μg QD 92 −0.014 (0.022) 0.109 (0.019) < .0001 0.073, 0.146
  Olodaterol 10 μg QD 91 0.004 (0.022) 0.127 (0.019) < .0001 0.091, 0.164
  Formoterol 12 μg BID 90 0.049 (0.022) 0.172 (0.019) < .0001 0.135, 0.209
Study 1222.25
Placebo 91 −0.048 (0.025)
  Olodaterol 5 μg QD 92 0.069 (0.025) 0.118 (0.018) < .0001 0.082, 0.154
  Olodaterol 10 μg QD 90 0.072 (0.025) 0.120 (0.018) < .0001 0.084, 0.157
  Formoterol 12 μg BID 90 0.107 (0.025) 0.155 (0.018) < .0001 0.119, 0.191
FEV 1 AUC 0–24
Study 1222.24
  Placebo 93 −0.092 (0.020)
  Olodaterol 5 μg QD 92 0.037 (0.021) 0.128 (0.017) < .0001 0.094, 0.163
  Olodaterol 10 μg QD 91 0.046 (0.021) 0.137 (0.017) < .0001 0.103, 0.172
  Formoterol 12 μg BID 90 0.065 (0.021) 0.156 (0.018) < .0001 0.122, 0.191
Study 1222.25
  Placebo 91 −0.035 (0.024)
  Olodaterol 5 μg QD 92 0.110 (0.024) 0.145 (0.016) < .0001 0.114, 0.176
  Olodaterol 10 μg QD 90 0.112 (0.024) 0.147 (0.016) < .0001 0.116, 0.179
  Formoterol 12 μg BID 90 0.121 (0.024) 0.156 (0.016) < .0001 0.125, 0.187

AUC0–12 = area under the curve from 0 to 12 h; AUC0–24 = area under the curve from 0 to 24 h; AUC12–24 = area under the curve from 12 to 24 h; BID = twice daily; FEV1 = forced expiratory volume in 1 sec; SE = standard error.

aBased on a mixed effects repeated measures model. The model includes treatment and period as fixed effects and center and patient within center as random effects, along with compound symmetry as a covariance structure for within−patient variation.