Table 1 Demographics and baseline values* of FAS-PFT randomised patients
Tiotropium | Placebo | Total | |
|---|---|---|---|
Total randomised (N) | 191 | 183 | 374 |
Male, n (%) | 96 (50.3) | 107 (58.5) | 203 (54.3) |
Age (years) | 64.7 (9.0) | 65.1 (9.3) | 64.9 (9.1) |
Smoking history (pack-years) | 36.9 (16.9) | 37.9 (17.7) | 37.4 (17.3) |
Screening (Visit 1) | |||
FEV1 (L) pre-bronchodilator | 1.25 (0.42) | 1.32 (0.44) | 1.28 (0.43) |
FEV1 % predicted normal | 47.91 (10.49) | 49.86 (10.71) | 48.86 (10.63) |
FEV1/FVC % | 55.24 (9.69) | 55.79 (10.01) | 55.51 (9.84) |
FVC (L) | 2.30 (0.75) | 2.41 (0.84) | 2.36 (0.80) |
NICE classification of COPD severity of obstruction, n (%)[2] | |||
Mild (FEV1 ≥50% predicted) | 86 (45.0) | 92 (50.3) | 178 (47.6) |
Moderate (30% ≤FEV1 <50% predicted) | 97 (50.8) | 88 (48.1) | 185 (49.5) |
Severe (FEV1 <30% predicted) | 8 (4.2) | 3 (1.6) | 11 (2.9) |
Pulmonary medication during baseline † | |||
LABA, n (%) | 55 (28.8) | 53 (29.0) | 108 (28.9) |
LABA, no ICS, n (%) | 6 (3.1) | 7 (3.8) | 13 (3.5) |
ICS, n (%) | 124 (64.9) | 113 (61.8) | 237 (63.4) |
ICS, no LABA, n (%) | 75 (39.3) | 67 (36.6) | 142 (38.0) |
LABA plus ICS, n (%) | 49 (25.7) | 46 (25.1) | 95 (25.4) |
No LABA, no ICS, n (%) | 61 (31.9) | 63 (34.4) | 124 (33.2) |
SABA use, occasions/week‡ | 3.83 (2.47) | 3.52 (2.51) | 3.68 (2.49) |