Background
Methods
Study design
Study population
Study endpoints
Calculation of the sample size
Statistical analysis
Results
Study population
Asian population | Non-Asian population | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
S1 | S2 | S3 | S1 | S2 | S3 | |||||||
FP/SAL | FP | FP/SAL | FP | FP/SAL | FP | FP/SAL | FP | FP/SAL | FP | FP/SAL | FP | |
n = 120 | n = 122 | n = 107 | n = 104 | n = 102 | n = 97 | n = 428 | n = 428 | n = 478 | n = 474 | n = 474 | n = 482 | |
Age, mean (SD), yearsa
| 37.2 (14.4) | 39.1 (14.4) | 41.9 (15.4) | 41.4 (13.5) | 45.8 (14.3) | 43.1 (12.4) | 35.8 (16.0) | 35.6 (15.8) | 40.0 (16.6) | 40.1 (17.2) | 43.7 (16.2) | 42.6 (16.3) |
Female, n (%)a
| 67 (56) | 75 (61) | 62 (58) | 61 (59) | 53 (52) | 63 (65) | 245 (57) | 241 (56) | 278 (58) | 288 (61) | 276 (58) | 279 (58) |
Height, mean (SD), cma
| 161.9 (9.5) | 158.6 (8.8) | 161.3 (8.9) | 162.7 (8.8) | 161.6 (9.5) | 161.3 (7.9) | 167.8 (9.8) | 167.7 (10.1) | 166.5 (10.2) | 166.5 (10.2) | 167.1 (10.1) | 166.6 (10.3) |
Weight, mean (SD), kga
| 60.8 (12.9) | 58.6 (11.7) | 61.5 (11.3) | 61.8 (11.1) | 63.2 (14.0) | 61.7 (10.6) | 72.4 (17.6) | 71.8 (17.9) | 72.6 (16.7) | 72.7 (17.9) | 74.5 (16.5) | 73.4 (16.4) |
BMI, mean (SD)a
| 23.15 (4.57) | 23.25 (3.94) | 23.59 (3.69) | 23.28 (3.41) | 24.07 (4.33) | 23.68 (3.37) | 25.63 (5.72) | 25.41 (5.73) | 26.16 (5.52) | 26.10 (5.56) | 26.59 (5.09) | 26.53 (5.46) |
Mean FEV1 at visit 2 (SD), Lb
| 2.08 (0.69)
n = 118
| 1.92 (0.68)
n = 121
| 1.91 (0.64)
n = 107
| 1.97 (0.58)
n = 104
| 1.93 (0.75)
n = 102
| 2.04 (0.68)
n = 95
| 2.61 (0.88)
n = 421
| 2.69 (0.82)
n = 423
| 2.53 (0.82)
n = 476
| 2.46 (0.82)
n = 473
| 2.36 (0.81)
n = 466
| 2.38 (0.79)
n = 472
|
Mean % predictedc FEV1 at visit 2 (SD), %b
| 68.6 (16.6)
n = 118
| 67.6 (17.0)
n = 121
| 66.7 (16.8)
n = 107
| 67.0 (15.6)
n = 104
| 67.3 (17.1)
n = 102
| 71.1 (16.8)
n = 95
| 78.8 (18.6)
n = 421
| 81.8 (18.0)
n = 423
| 80.4 (17.6)
n = 476
| 79.3 (18.2)
n = 473
| 76.2 (18.6)
n = 466
| 77.1 (17.6)
n = 472
|
Median pre-randomisation reversibility, (min., max.), % | 21.4 (10.5, 95.2)
n = 91
| 20.0 (9.0, 112.5)
n = 98
| 25.0 (2.7, 124.7)
n = 87
| 24.0 (11.1, 78.9)
n = 80
| 25.3 (4.2, 92.0)
n = 63
| 20.2 (8.3, 68.6)
n = 67
| 23.8 (1.0, 95.7)
n = 318
| 22.0 (2.5, 97.0)
n = 324
| 21.4 (−0.6, 123.6)
n = 346
| 21.6 (3.7, 111.5)
n = 346
| 22.2 (−0.4, 115.3)
n = 356
| 21.9 (3.1, 224.0)
n = 366
|
Mean am PEF (SD), L/min | 310.5 (76.3)
n = 120
| 299.0 (72.7)
n = 122
| 312.3 (92.3)
n = 107
| 311.0 (70.9)
n = 104
| 320.1 (84.2)
n = 102
| 327.9 (90.5)
n = 97
| 353.8 (92.9)
n = 427
| 358.4 (93.8)
n = 427
| 356.9 (98.0)
n = 478
| 350.7 (96.5)
n = 474
| 350.4 (100.8)
n = 473
| 352.5 (97.0)
n = 482
|
Mean % predictedb am PEF (SD), % | 71.1 (14.1)
n = 120
| 71.9 (14.4)
n = 122
| 74.1 (18.4)
n = 107
| 72.7 (15.9)
n = 104
| 74.8 (14.4)
n = 102
| 77.5 (17.2)
n = 97
| 76.9 (14.5)
n = 427
| 77.9 (14.1)
n = 427
| 79.4 (15.3)
n = 478
| 79.3 (16.2)
n = 474
| 78.4 (16.2)
n = 473
| 79.2 (16.0)
n = 482
|
Mean daily rescue usage, (SD) | 1.9 (1.6)
n = 120
| 1.7 (1.3)
n = 122
| 1.7 (1.3)
n = 107
| 1.5 (1.1)
n = 103
| 1.5 (1.5)
n = 102
| 1.6 (1.4)
n = 97
| 2.0 (1.7)
n = 426
| 1.8 (1.5)
n = 428
| 1.8 (1.5)
n = 478
| 1.8 (1.5)
n = 473
| 2.0 (1.4)
n = 473
| 2.0 (1.4)
n = 482
|
Median night-time awakenings, (min., max.) | 0.5 (0, 3)
n = 120
| 0.5 (0, 3)
n = 122
| 0.2 (0, 3)
n = 107
| 0.2 (0, 2)
n = 104
| 0.2 (0, 2)
n = 102
| 0.3 (0, 4)
n = 95
| 0.4 (0, 4)
n = 425
| 0.3 (0, 4)
n = 427
| 0.2 (0, 3)
n = 476
| 0.2 (0, 3)
n = 471
| 0.3 (0, 4)
n = 471
| 0.2 (0, 3)
n = 479
|
Mean asthma symptom score, (SD) | 1.9 (0.8)
n = 120
| 1.7 (0.8)
n = 121
| 1.7 (0.9)
n = 107
| 1.6 (0.8)
n = 104
| 1.6 (0.9)
n = 102
| 1.8 (1.0)
n = 97
| 1.8 (0.8)
n = 427
| 1.7 (0.9)
n = 428
| 1.8 (0.9)
n = 478
| 1.8 (0.9)
n = 473
| 2.0 (0.9)
n = 472
| 1.9 (0.9)
n = 482
|
Patients with atopy, n (%)a
| 54 (45) | 46 (38) | 54 (50) | 59 (57) | 62 (61) | 46 (47) | 259 (61) | 253 (59) | 298 (62) | 278 (59) | 300 (63) | 290 (60) |
Patients with unknown atopy, n (%)a
| 8 (7) | 10 (8) | 13 (12) | 9 (9) | 18 (18) | 10 (10) | 46 (11) | 34 (8) | 31 (6) | 25 (5) | 32 (7) | 30 (6) |