Tiotropium 5 µg | Tiotropium 2.5 µg | Placebo | |
Males | |||
Subjects | 365 | 373 | 366 |
Any AEs | 195 (53.4) | 190 (50.9) | 201 (54.9) |
Drug-related AEs | 5 (1.4) | 0 | 5 (1.4) |
AEs leading to discontinuation | 2 (0.5) | 0 | 3 (0.8) |
Serious AEs | 7 (1.9) | 6 (1.6) | 4 (1.1) |
AEs reported in ≥5% and ≥10 patients# | |||
Asthma exacerbation/worsening | 75 (20.5) | 73 (19.6) | 94 (25.7) |
Decreased peak expiratory flow rate | 38 (10.4) | 49 (13.1) | 44 (12.0) |
Nasopharyngitis/rhinopharyngitis | 29 (7.9) | 34 (9.1) | 34 (9.3) |
Viral respiratory tract infection | 16 (4.4) | 14 (3.8) | 22 (6.0) |
Respiratory tract infection | 14 (3.8) | 11 (2.9) | 20 (5.5) |
Females | |||
Subjects | 195 | 186 | 206 |
Any AEs | 88 (45.1) | 96 (51.6) | 109 (52.9) |
Drug-related AEs | 2 (1.0) | 1 (0.5) | 3 (1.5) |
AEs leading to discontinuation | 0 | 0 | 2 (1.0) |
Serious AEs | 3 (1.5) | 2 (1.1) | 9 (4.4) |
AEs reported in ≥5% and ≥10 patients# | |||
Asthma exacerbation/worsening | 35 (17.9) | 42 (22.6) | 49 (23.8) |
Decreased peak expiratory flow rate | 17 (8.7) | 15 (8.1) | 24 (11.7) |
Nasopharyngitis/rhinopharyngitis | 15 (7.7) | 12 (6.5) | 15 (7.3) |
Viral respiratory tract infection | 11 (5.6) | 10 (5.4) | 8 (3.9) |
Data are presented as n or n (%). Percentages are calculated using total number of patients per treatment as the denominator. #: in at least one treatment group.