Table 3.
Asthma control days (%), rescue medication-free days (%), symptom-free days (%), and awakening-free nights (%): mean change from baseline to week 12, Full Analysis Set
|
Characteristic |
Treatment group |
|||
|---|---|---|---|---|
| Fluticasone/formoterol 100/10 μg b.i.d. N = 115 | Fluticasone 100 μg b.i.d. N = 117 | Formoterol 10 μg b.i.d. N = 116 | Placebo b.i.d N = 111 | |
|
Asthma control days (%) |
n = 109 |
n = 114 |
n = 112 |
n = 105 |
| Baselinea, mean (SD) |
12.8 (20.14) |
14.3 (22.62) |
11.5 (19.21) |
10.0 (18.11) |
| Week 12, mean (SD) |
69.1 (37.69) |
58.3 (42.02) |
53.4 (40.11) |
46.0 (41.22) |
| Change to week 12 |
|
|
|
|
| Mean (SD) |
56.3 (39.11) |
44.0 (39.49) |
41.9 (42.13) |
36.0 (39.27) |
| Difference from fluticasone/formoterol 100/10 μg b.i.d.b | ||||
| p-value* |
|
0.017† |
0.117 |
0.012† |
|
Rescue medication-free days (%) |
n = 112 |
n = 116 |
n = 115 |
n = 109 |
| Baselinea, mean (SD) |
21.8 (24.38) |
21.4 (25.55) |
19.5 (24.51) |
17.2 (20.14) |
| Week 12, mean (SD) |
77.7 (32.12) |
64.8 (39.49) |
61.4 (37.19) |
56.6 (39.95) |
| Change to week 12 |
|
|
|
|
| Mean (SD) |
55.9 (36.43) |
43.3 (37.69) |
41.9 (39.49) |
39.4 (38.69) |
| Difference from fluticasone/formoterol 100/10 μg b.i.d.b | ||||
|
p-value* |
|
0.020† |
0.125 |
0.012† |
|
Symptom-free days (%) |
n=110 |
n=114 |
n=115 |
n=108 |
| Baselinea, mean (SD) |
28.0 (26.72) |
28.6 (29.97) |
22.6 (27.01) |
22.7 (27.75) |
| Week 12, mean (SD) |
77.4 (35.21) |
65.9 (38.59) |
60.5 (38.67) |
58.3 (38.99) |
| Change to week 12 |
|
|
|
|
| Mean (SD) |
49.4 (38.17) |
37.3 (39.79) |
38.0 (42.64) |
35.6 (42.18) |
| Difference from fluticasone/formoterol 100/10 μg b.i.d.b | ||||
|
p-value* |
|
0.027† |
0.195 |
0.151 |
|
Awakening-free nights (%) |
n = 112 |
n = 116 |
n = 115 |
n = 108 |
| Baselinea, mean (SD) |
59.1 (33.79) |
62.1 (33.73) |
62.9 (34.51) |
56.3 (37.40) |
| Week 12, mean (SD) |
87.9 (26.73) |
87.5 (26.77) |
82.6 (31.57) |
77.2 (34.17) |
| Change to week 12 |
|
|
|
|
| Mean (SD) |
28.8 (33.91) |
25.4 (35.92) |
19.6 (35.68) |
20.9 (41.05) |
| Difference from fluticasone/formoterol 100/10 μg b.i.d.b | ||||
| p-value* | 0.790 | 0.055 | 0.052 | |
b.i.d. = twice daily; N = total number of patients; n = number of patients in treatment group; FAS = full analysis set; SD = standard deviation.
a. Baseline was the 7-day average calculated on the last 7 days prior to the first dose of study drug.
b. Analysis method was Cochran-Mantel-Haenszel using van Elteren’s method for combining Wilcoxon rank sum test results from independent strata, with previous steroid use and site as the strata for the analysis.
*All p values were exploratory.
† p ≤ 0.050 versus fluticasone/formoterol 100/10 μg b.i.d. combination therapy but not statistically significant as per the sequential gatekeeping approach.