Table 2.
Fev1 Auc(0–24h) Response, Secondary Fev1-based End Point Responses, and Mean Morning and Evening PEF Responses (Last Week) at the End of the Two 4-week Treatment Periods
| Adjusted differenceabetween treatments | |||
|---|---|---|---|
| Treatment and parameter | Adjusted mean responsea ± SE | Mean ± SE | 95% CI |
| FEV1 AUC(0–24h), mL | |||
| Tiotropium Respimat® 5 μg QD (n = 97) | 217 ± 31 | −2 ± 18 | −38, 34 |
| Tiotropium Respimat® 2.5 μg BID (n = 98) | 219 ± 31 | ||
| FEV1 AUC(0–12h), mL | |||
| Tiotropium Respimat® 5 μg QD (n = 97) | 192 ± 31 | 10 ± 21 | −32, 52 |
| Tiotropium Respimat® 2.5 μg BID (n = 98) | 182 ± 31 | ||
| FEV1 AUC(12–24h), mL | |||
| Tiotropium Respimat® 5 μg QD (n = 97) | 243 ± 33 | −14 ± 18 | −50, 22 |
| Tiotropium Respimat® 2.5 μg BID (n = 98) | 256 ± 33 | ||
| Peak FEV1(0–24h), mL | |||
| Tiotropium Respimat® 5 μg QD (n = 97) | 451 ± 31 | −14 ± 18 | −51, 23 |
| Tiotropium Respimat® 2.5 μg BID (n = 98) | 465 ± 31 | ||
| Trough FEV1, mL | |||
| Tiotropium Respimat® 5 μg QD (n = 97) | 207 ± 34 | 4 ± 32 | −60, 68 |
| Tiotropium Respimat® 2.5 μg BID (n = 98) | 203 ± 33 | ||
| Morning PEFb, L/min | |||
| Tiotropium Respimat® 5 μg QD (n = 96) | 33 ± 6 | 2 ± 4 | −6, 11 |
| Tiotropium Respimat® 2.5 μg BID (n = 98) | 31 ± 6 | ||
| Evening PEFb, L/min | |||
| Tiotropium Respimat® 5 μg QD (n = 96) | 34 ± 6 | −0.3 ± 4 | −8, 8 |
| Tiotropium Respimat® 2.5 μg BID (n = 98) | 34 ± 6 | ||
Full analysis set.
Adjusted for treatment, period, patient, and baseline. bBased on the last week before randomization.
Common baseline mean ± standard deviation: FEV1 = 2634 ± 773 mL. Common baseline mean ± standard deviation: morning PEF = 389 ± 121 L/min; evening PEF = 402 ± 123 L/min.
BID, twice daily; CI, confidence interval; FEV1, forced expiratory volume in 1 second; FEV1 AUC(0–12h), forced expiratory volume in 1 second area under the curve from 0 to 12 hours (night-time period); FEV1 AUC(0–24h), forced expiratory volume in 1 second area under the curve from 0 to 24 hours; FEV1 AUC(12–24h), forced expiratory volume in 1 second area under the curve from 12 to 24 hours (daytime period); PEF, peak exploratory flow; QD, once daily; SE, standard error.