Patient flow and withdrawals
| B/F | B | F | Placebo | Total | |
| Patients enrolled | 1141 | ||||
| Patients withdrawn during run-in | 119 | ||||
| Patients randomised | 254 | 257 | 255 | 256 | 1022 |
| Patients withdrawn after randomisation# | 74 (29) | 102 (40) | 111 (44) | 106 (41) | 393 (38) |
| Patients withdrawn due to COPD worsening¶ | 28 (11) | 46 (18) | 59 (23) | 60 (23) | 193 (19) |
| Patients withdrawn due to adverse event other than COPD worsening | 20 (8) | 21 (8) | 20 (8) | 11 (4) | 72 (7) |
| Patients lost to follow-up | 0 (0) | 2 (0.8) | 3 (1.2) | 3 (1.2) | 8 (0.8) |
| Eligibility criteria not fulfilled | 4 (1.6) | 4 (1.6) | 4 (1.6) | 6 (2.3) | 18 (1.8) |
| Other reasons | 22 (8.7) | 29 (11.3) | 25 (9.8) | 26 (10.2) | 102 (10.0) |
| Patients completing study | 180 (71) | 155 (60) | 144 (56) | 150 (59) | 629 (62) |
Data are presented as n (% of randomised patients per group) unless otherwise stated
B: budesonide
F: formoterol
COPD: chronic obstructive pulmonary disease
#: p=0.001 budesonide/formoterol versus placebo, p=0.037 budesonide/formoterol versus budesonide, p<0.001 budesonide/formoterol versus formoterol, p=0.223 budesonide versus placebo, p=0.950 formoterol versus placebo (Cox proportional hazards model)
¶: p<0.001 budesonide/formoterol versus placebo and versus formoterol, p=0.038 budesonide/formoterol versus budesonide, p=0.031 budesonide versus placebo, p=0.616 formoterol versus placebo (Cox proportional hazards model)