Trial [ref.] | Treatment arm | Type of AE | ||
Any AE | Serious AEs | Drug-related AEs | ||
NCT00365560# [54] | Tiotropium 10 µg once daily (n=103) | 51 (49.5) | 1 (1.0) | 5 (4.9) |
Tiotropium 5 µg once daily (n=104) | 44 (42.3) | 2 (1.9) | 1 (1.0) | |
Placebo once daily (n=103) | 41 (39.8) | 2 (1.9) | 1 (1.0) | |
NCT00350207¶ [55] | Tiotropium 5 µg once daily (n=128) | 51 (39.8) | 2 (1.6) | 6 (4.7) |
Salmeterol 50 µg twice daily (n=134) | 56 (41.8) | 7 (5.2) | 3 (2.2) | |
Placebo (n=126) | 52 (41.3) | 1 (0.8) | 4 (3.2) | |
NCT01233284¶ [56] | Tiotropium 5 µg once daily (n=146) | 23 (15.8) | 2 (1.4) | 3 (2.1) |
Tiotropium 2.5 µg once daily (n=147) | 20 (13.6) | 0 | 0 | |
Tiotropium 1.25 µg once daily (n=146) | 14 (9.6) | 0 | 2 (1.4) | |
NCT01152450¶ [57] | Tiotropium 5 µg once daily (n=90) | 22 (24.4) | 2 (2.2) | 4 (4.4) |
Tiotropium 2.5 µg twice daily (n=90) | 26 (28.9) | 0 | 3 (3.3) | |
Placebo once daily (n=92) | 26 (28.3) | 1 (1.1) | 3 (3.3) | |
NCT00772538, NCT00776984+ [58] | Tiotropium 5 µg once daily (n=456) | 335 (73.5) | 37 (8.1) | 26 (5.7) |
Placebo once daily (n=456) | 366 (80.3) | 40 (8.8) | 21 (4.6) | |
NCT01172808, NCT01172821§ [59] | Tiotropium 5 µg once daily (n=517) | 296 (57.3) | 11 (2.1) | 38 (7.4) |
Tiotropium 2.5 µg once daily (n=519) | 302 (58.2) | 12 (2.3) | 36 (6.9) | |
Salmeterol 50 µg twice daily (n=541) | 294 (54.3) | 11 (2.0) | 28 (5.2) | |
Placebo (n=523) | 309 (59.1) | 14 (2.7) | 28 (5.4) |
Data are presented as n (%). All analyses performed on the treated set. AE: adverse event. #: phase II study in adults with severe asthma; ¶: phase II study in adults with moderate asthma; +: phase III study in adults with severe asthma; §: phase III study in adults with moderate asthma.