Table 1.
Design | Patients | Indacaterol dose, μg | Pbo | For | Sal | Tio | |||||
---|---|---|---|---|---|---|---|---|---|---|---|
18.75 | 37.5 | 75 | 150 | 300 | 600 | ||||||
Cross-over, 14-day | 96 | 144‡ | 72 | 72 | |||||||
Parallel-group, 52-week | 1732 | 437 | 428 | 432 | 435 | ||||||
Parallel-group 26-week | 2059 | 130 | 420 | 418 | 123 | 425 | 123 | 420 | |||
Crossover, 14-day | 68 | 66 | 66 | 65 | |||||||
Parallel-group, 12-week | 416 | 211 | 205 | ||||||||
Parallel-group, 12-week | 347* | 114 | 116 | 117 | |||||||
Parallel-group, 26-week | 563 | 188 | 188 | 187 | |||||||
Parallel-group, 26-week | 1002 | 333 | 335 | 334 | |||||||
Parallel-group, 12-week | 323 | 163 | 160 | ||||||||
Parallel-group, 12-week | 318 | 159 | 159 | ||||||||
Parallel-group, 12-week | 552 | 92 | 91 | 94 | 92 | 91 | 92 | ||||
7476 | 92 | 91 | 546 | 1358 | 1369 | 551 | 2249 | 558 | 563 | 420 |
All studies were placebo-controlled. Values are numbers of patients (the sum of totals across the columns for indacaterol dose and comparators is greater than the total number of patients randomized due to the inclusion of cross-over studies). *Asian patients; ‡73 morning dosing vs 71 evening dosing. Pbo = placebo; For = formoterol 12 μg bid; Sal = salmeterol 50 μg bid; Tio = tiotropium 18 μg qd