Number of moderate/severe COPD exacerbations
| ITT group | PPP group | |||
|---|---|---|---|---|
| Placebo(n = 318) | Salmeterol(n = 316) | Placebo(n = 195) | Salmeterol(n = 206) | |
| ITT, intent-to-treat; PPP, per protocol population; ICS, inhaled corticosteroid; LABA, long acting β agonist. | ||||
| *p values and confidence intervals were based on the distribution of data. | ||||
| Median (range) | 0.93 (0.0–13.0) | 0.00 (0.0–9.8) | 0.93 (0.0–5.6) | 0.00 (0.0–5.0) |
| Mean (SD) per year | 1.18 (1.97) | 0.93 (1.46) | 0.83 (1.06) | 0.58 (0.91) |
| p value* | 0.27 | 0.007 | ||
| ITT subgroup analysis: | ||||
| ICS users | ||||
| Median (range) | 0.93 (0.0–13.0) | 0.93 (0.0–9.8) | ||
| Mean (SD) | 1.43 (2.24) | 1.05 (1.55) | ||
| Non-ICS users | ||||
| Median (range) | 0.0 (0.0–7.1) | 0.0 (0.0–6.0) | ||
| Mean (SD) | 0.74 (1.24) | 0.74 (1.28) | ||
| Used LABAs pre-study | ||||
| Median (range) | 0.93 (0.0–13.0) | 0.93 (0.0–5.0) | ||
| Mean (SD) | 1.91 (2.97) | 0.99 (1.34) | ||
| Did not use LABAs pre-study | ||||
| Median (range) | 0.0 (0.0–13.0) | 0.0 (0.0–9.8) | ||
| Mean (SD) | 0.98 (1.54) | 0.92 (1.49) | ||
| Used anticholinergics | ||||
| Median (range) | 0.93 (0.0–13.0) | 0.00 (0.0–9.8) | ||
| Mean (SD) | 1.49 (2.40) | 1.02 (1.63) | ||
| Did not use anticholinergics | ||||
| Median (range) | 0.93 (0.0–13.0) | 0.00 (0.0–6.5) | ||
| Mean (SD) | 1.07 (1.78) | 0.90 (1.40) | ||
| Used xanthines | ||||
| Median (range) | 0.93 (0.0–13.0) | 0.00 (0.0–5.8) | ||
| Mean (SD) | 1.07 (1.66) | 0.95 (1.34) | ||
| Did not use xanthines | ||||
| Median (range) | 0.00 (0.0–13.0) | 0.00 (0.0–9.8) | ||
| Mean (SD) | 1.24 (2.12) | 0.92 (1.53) | ||
| No of exacerbations (ITT) | ||||
| 0 | 155 (49%) | 170 (54%) | 93 (48%) | 121 (59%) |
| 1 | 88 (28%) | 87 (28%) | 61 (31%) | 61 (30%) |
| 2 | 42 (13%) | 33 (10%) | 26 (13%) | 16 (8%) |
| ⩾3 | 33 (10%) | 26 (8%) | 15 (8%) | 8 (4%) |