Table 2.
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.