Table 5 COPD exacerbations by treatment and according to baseline disease severity during the trial in randomised patients
Tiotropium | Placebo | |
|---|---|---|
Number of patients treated | 200 | 195 |
≥1 COPD exacerbation, n (%) | 19 (9.5) | 35 (17.9)* |
1 exacerbation, n (%) | 15 (7.5) | 28 (14.4) |
2 exacerbations, n (%) | 4 (2.0) | 5 (2.6) |
3 exacerbations, n (%) | 0 (0.0) | 2 (1.0) |
Baseline disease severity, proportion (%) | ||
Mild (FEV1 ≥50% predicted) | 6/88 (6.8) | 16/95 (16.8)* |
Moderate (30% ≤FEV1 <50% predicted) | 11/104 (10.6) | 18/96 (18.8) |
Severe (FEV1 <30% predicted) | 2/8 (25.0) | 1/4 (25.0) |
Moderate/severe (FEV1 <50% predicted) | 13/112 (11.6) | 19/100 (19.0) |
Treatment change, n (%)† | ||
Antibiotics | 12 (6.0) | 13 (6.7) |
+ bronchodilator | 4 (2.0) | |
+ bronchodilator + oral steroid | 1 (0.5) | 1 (0.5) |
+ oral steroid | 2 (1.0) | 12 (6.2) |
Oral steroid | 3 (1.5) | |
Bronchodilator | 1 (0.5) | 1 (0.5) |
+ inhaled steroid | 3 (1.5) | |
Inhaled steroid | 1 (0.5) |