Table 4.
Adjusted mean FEV 1 AUC 0–3 , peak FEV 1 , and trough FEV 1 responses (L) compared to placebo after 6 weeks
| Treatment | Adjusted amean (95% CI) difference from placebo at 6 weeks | ||||
|---|---|---|---|---|---|
| FEV 1 AUC 0–3 | n | Adjusted mean (SE) | Mean (SE) | Pvalue | 95% CI |
| Study 1222.24 | |||||
| Placebo | 93 | −0.030 (0.020) | |||
| Olodaterol 5 μg QD | 92 | 0.134 (0.021) | 0.164 (0.019) | < .0001 | 0.126, 0.201 |
| Olodaterol 10 μg QD | 91 | 0.135 (0.021) | 0.164 (0.019) | < .0001 | 0.127, 0.202 |
| Formoterol 12 μg BID | 90 | 0.168 (0.021) | 0.198 (0.019) | < .0001 | 0.160, 0.236 |
| Study 1222.25 | |||||
| Placebo | 91 | 0.004 (0.024) | |||
| Olodaterol 5 μg QD | 92 | 0.190 (0.025) | 0.186 (0.019) | < .0001 | 0.149, 0.223 |
| Olodaterol 10 μg QD | 90 | 0.202 (0.025) | 0.198 (0.019) | < .0001 | 0.162, 0.235 |
| Formoterol 12 μg BID | 90 | 0.217 (0.025) | 0.213 (0.019) | < .0001 | 0.176, 0.250 |
| Peak FEV 1 | |||||
| Study 1222.24 | |||||
| Placebo | 93 | 0.034 (0.022) | |||
| Olodaterol 5 μg QD | 92 | 0.208 (0.022) | 0.174 (0.020) | < .0001 | 0.135, 0.214 |
| Olodaterol 10 μg QD | 91 | 0.200 (0.022) | 0.166 (0.020) | < .0001 | 0.127, 0.206 |
| Formoterol 12 μg BID | 90 | 0.251 (0.022) | 0.218 (0.020) | < .0001 | 0.178, 0.257 |
| Study 1222.25 | |||||
| Placebo | 91 | 0.076 (0.026) | |||
| Olodaterol 5 μg QD | 92 | 0.268 (0.026) | 0.192 (0.019) | < .0001 | 0.154, 0.230 |
| Olodaterol 10 μg QD | 90 | 0.273 (0.026) | 0.197 (0.020) | < .0001 | 0.158, 0.235 |
| Formoterol 12 μg BID | 90 | 0.293 (0.026) | 0.217 (0.020) | < .0001 | 0.178, 0.255 |
| Trough FEV 1 | |||||
| Study 1222.24 | |||||
| Placebo | 93 | −0.093 (0.023) | |||
| Olodaterol 5 μg QD | 92 | 0.012 (0.024) | 0.106 (0.021) | < .0001 | 0.064, 0.147 |
| Olodaterol 10 μg QD | 91 | 0.020 (0.024) | 0.113 (0.021) | < .0001 | 0.072, 0.155 |
| Formoterol 12 μg BID | 90 | 0.040 (0.024) | 0.133 (0.021) | < .0001 | 0.092, 0.175 |
| Study 1222.25 | |||||
| Placebo | 91 | 0.012 (0.030) | |||
| Olodaterol 5 μg QD | 92 | 0.109 (0.030) | 0.097 (0.026) | .0003 | 0.045, 0.148 |
| Olodaterol 10 μg QD | 90 | 0.115 (0.030) | 0.103 (0.026) | .0001 | 0.051, 0.155 |
| Formoterol 12 μg BID | 90 | 0.093 (0.030) | 0.080 (0.026) | .0026 | 0.028, 0.132 |
AUC0–3 = area under the curve from 0 to 3 h; BID = twice daily; FEV1 = forced expiratory volume in 1 sec; QD = once daily; 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.