TABLE 2

Overview of adverse events from clinical trials of tiotropium Respimat in patients with symptomatic asthma

Trial [ref.]Treatment armType of AE
Any AESerious AEsDrug-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)00
Tiotropium 1.25 µg once daily (n=146)14 (9.6)02 (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)03 (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.