Treatment group | ||||
---|---|---|---|---|
Fluticasone/formoterol 100/10 μg b.i.d. N = 118 | Fluticasone 100 μg b.i.d. N = 119 | Formoterol 10 μg b.i.d. N = 120 | Placebo b.i.d. N = 118 | |
Any AE, n (%) | 38 (32.2) | 47 (39.5) | 44 (36.7) | 46 (39.0) |
Any serious AE, n (%) | 1 (0.8) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Any severe AE, n (%) | 6 (5.1) | 6 (5.0) | 11 (9.2) | 16 (13.6) |
Any AE leading to study discontinuationa, n (%) | 4 (3.4) | 5 (4.2) | 9 (7.5) | 17 (14.4) |
Any AE with probably or possible relationship to study drug, n (%) | 5 (4.2) | 9 (7.6) | 10 (8.3) | 12 (10.2) |
Any AE leading to death, n (%) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Treatment-emergent AEs reported for >2% of patients in any treatment group, n (%) | ||||
Infections and infestations | 20 (16.9) | 27 (22.7) | 14 (11.7) | 15 (12.7) |
Upper respiratory tract infection | 7 (5.9) | 6 (5.0) | 3 (2.5) | 4 (3.4) |
Nasopharyngitis | 3 (2.5) | 9 (7.6) | 3 (2.5) | 3 (2.5) |
Urinary tract infection | 3 (2.5) | 3 (2.5) | 1 (0.8) | 1 (0.8) |
Respiratory, thoracic and mediastinal disorders | 8 (6.8) | 8 (6.7) | 14 (11.7) | 17 (14.4) |
Asthmab | 3 (2.5) | 4 (3.4) | 9 (7.5) | 14 (11.9) |
Cough | 4 (3.4) | 2 (1.7) | 1 (0.8) | 1 (0.8) |
Nervous system disorders | 5 (4.2) | 10 (8.4) | 6 (5.0) | 11 (9.3) |
Headache | 2 (1.7) | 6 (5.0) | 3 (2.5) | 9 (7.6) |
Gastrointestinal disorders | 3 (2.5) | 5 (4.2) | 3 (2.5) | 5 (4.2) |
Diarrhoea | 2 (1.7) | 0 (0.0) | 1 (0.8) | 3 (2.5) |