Table 3.
(A) The mean (SEM) treatment differences at week 48 for primary and secondary efficacy variables and (B) the difference between post-bronchodilator FEV1 at baseline and post-dose on test day 337
| (A) Treatment differences |
Treatment† comparison |
||
|---|---|---|---|
| Tiotropium Respimat® SMI 5 μg–placebo | Tiotropium Respimat® SMI 10 μg–placebo | Tiotropium Respimat® SMI 10 μg–5 μg | |
| Primary | |||
| Trough (24-h post-dose) FEV1 (L) response (n = 1897) | 0.127* (0.013) | 0.150* (0.013) | 0.023 (0.013) |
| [95% CI] | [0.101, 0.153] | [0.124, 0.175] | [−0.002, 0.048] |
| SGRQ total score (n = 1798) | −3.5* (0.7) | −3.8* (0.7) | −0.4 (0.7) |
| [95% CI] | [−4.9, −2.1] | [−5.3, −2.4] | [−1.7, 1.0] |
| Mahler TDI focal score (n = 1798) | 1.05* (0.17) | 1.08* (0.17) | 0.02 (0.16) |
| [95% CI] | [0.73, 1.38] | [0.75, 1.40] | [−0.29, 0.34] |
| Secondary | |||
| ‡Rescue medication use (occasions per day) [n = 1900] | −0.6* (0.1) | −0.7* (0.1) | −0.1 (0.1) |
| [95% CI] | [−0.8, −0.4] | [−0.9, −0.5] | [−0.3, 0.1] |
| ‡Morning PEFR (L/min) (n = 1900) | 22* (3) | 28* (3) | 5 (3) |
| [95% CI] | [17, 28] | [22, 33] | [0, 10] |
| ‡Evening PEFR (L/min) (n = 1900) | 27* (3) | 33* (3) | 6** (3) |
| [95% CI] | [22, 32] | [28, 39] | [1, 12] |
| (B) Treatment comparison | Tiotropium Respimat®SMI 5 μg | Tiotropium Respimat®SMI 10 μg | Placebo |
| Post-bronchodilator FEV1 at baseline | 1.281 | 1.281 | 1.282 |
| Post-bronchodilator FEV1 on test day 337 (30 minutes post-dose) | 1.242 | 1.270 | 1.053 |
*
P < 0.0001 vs placebo;
**
P < 0.05.
Notes:
†
Adjusted for smoking status at entry, center and baseline value. A last observation carried forward approach was used for all missing data except rescue medication use and PEFR
‡
These data reflect the overall mean.
Abbreviations: FEV1, forced expiratory volume in 1 second; PEFR, peak expiratory flow rate; SGRQ, St George’s Respiratory Questionnaire; TDI, Transition Dyspnea Index; SMI, Soft Mist™ Inhaler.