Table 3.
Number of patients (and % of total) with respiratory events suggestive of administration-related bronchoconstriction during the 30 minutes immediately after inhalation of study treatment on at least one test day. Patients are grouped according to the worst category of event experienced. See text for detailed definition of categories
| Number of test days on which event occurred | Tiotropium Respimat® 5 μg (n = 670) | Tiotropium Respimat® 10 μg (n = 667) | Placebo Respimat® (n = 653) | |
|---|---|---|---|---|
| Number of patient tests (n) | 4850 | 4731 | 4232 | |
| Category A (aggravated bronchospasm) | At least 1 | 0 (0) | 0 (0) | 0 (0) |
| Category B (two or more of rescue use, ARBI, and 15% fall in FEV1) | At least 1 | 2 (0.3) | 3 (0.4) | 1 (0.2) |
| 1 | 2 | 3 | 1 | |
| Category C (either rescue use or ARBI) | At least 1 | 8 (1.2) | 5 (0.7) | 8 (1.2) |
| 1 | 7 | 5 | 8 | |
| 2 | 0 | 0 | 0 | |
| 3 | 1 | 0 | 0 | |
| Category D (15% fall in FEV1) | At least 1 | 45 (6.7) | 64 (9.6) | 95 (14.5) |
| 1 | 33 | 52 | 67 | |
| 2 | 8 | 8 | 20 | |
| 3 | 4 | 4 | 7 | |
| 4 | 0 | 0 | 1 | |
| None of the above | At least 1 | 615 (91.8) | 595 (89.2) | 549 (84.1) |
| 1 | 14 | 13 | 37 | |
| 2 | 23 | 30 | 53 | |
| 3 | 21 | 25 | 25 | |
| 4 | 11 | 17 | 22 | |
| 5 | 18 | 17 | 20 | |
| 6 | 1 | 12 | 19 | |
| 7 | 17 | 23 | 11 | |
| 8 | 501 | 458 | 362 |
Abbreviations: ARBI, administration-related bronchoconstriction indicator; FEV1, forced expiratory volume in one second.