Table 4.
Secondary efficacy variable responses (L) after 12 weeks
| Trial/treatment | Change from baseline
|
Mean difference from tiotropium + placebo
|
||
|---|---|---|---|---|
| n | Mean (SE), L | Mean (SE), L | 95% CI | |
| Peak FEV1 | ||||
| ANHELTO 1 | ||||
| Tiotropium + placebo | 564 | 0.270 (0.010) | ||
| Olodaterol + tiotropium | 563 | 0.389 (0.010) | 0.119 (0.014) | 0.090, 0.147 |
| ANHELTO 2 | ||||
| Tiotropium + placebo | 566 | 0.271 (0.011) | ||
| Olodaterol + tiotropium | 563 | 0.371 (0.011) | 0.100 (0.015) | 0.071, 0.129 |
| FVC AUC0–3 | ||||
| ANHELTO 1 | ||||
| Tiotropium + placebo | 564 | 0.292 (0.017) | ||
| Olodaterol + tiotropium | 563 | 0.438 (0.017) | 0.146 (0.024) | 0.100, 0.192 |
| ANHELTO 2 | ||||
| Tiotropium + placebo | 566 | 0.306 (0.017) | ||
| Olodaterol + tiotropium | 563 | 0.424 (0.017) | 0.118 (0.023) | 0.072, 0.164 |
| Peak FVC | ||||
| ANHELTO 1 | ||||
| Tiotropium + placebo | 564 | 0.433 (0.017) | ||
| Olodaterol + tiotropium | 563 | 0.586 (0.017) | 0.153 (0.024) | 0.106, 0.201 |
| ANHELTO 2 | ||||
| Tiotropium + placebo | 566 | 0.457 (0.017) | ||
| Olodaterol + tiotropium | 563 | 0.562 (0.017) | 0.104 (0.024) | 0.057, 0.152 |
| Trough FVC | ||||
| ANHELTO 1 | ||||
| Tiotropium + placebo | 551 | 0.213 (0.016) | ||
| Olodaterol + tiotropium | 548 | 0.276 (0.016) | 0.063 (0.022) | 0.019, 0.106 |
| ANHELTO 2 | ||||
| Tiotropium + placebo | 555 | 0.235 (0.015) | ||
| Olodaterol + tiotropium | 550 | 0.269 (0.015) | 0.034 (0.022) | −0.008, 0.076 |
Abbreviations: CI, confidence interval; FEV1, forced expiratory volume in 1 second; FVC, forced vital capacity; AUC0–3, area under the curve from 0–3 hours; SE, standard error.