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 | |
Rescue medication use (inhalations/day) | n = 112 | n = 116 | n = 115 | n = 109 |
Baselinea, mean (SD) | 2.8 (2.05) | 3.0 (2.24) | 3.0 (2.07) | 3.0 (1.68) |
Change to week 12 | ||||
Mean (SE)b | −2.22 (0.165) | −1.64 (0.160) | −1.62 (0.163) | −1.16 (0.162) |
Difference from fluticasone/formoterol 100/10 μg b.i.d.b | ||||
LS Mean (SE) | −0.58 (0.217) | −0.60 (0.218) | −1.06 (0.222) | |
95% CI | −1.01, -0.15 | −1.03, -0.17 | −1.50, -0.63 | |
p-value* | 0.008** | 0.006** | <0.001** | |
Asthma symptom scores | n = 110 | n = 114 | n = 115 | n = 108 |
Baselinea, mean (SD) | 1.0 (0.60) | 1.0 (0.64) | 1.1 (0.61) | 1.1 (0.62) |
Change to week 12 | ||||
LS Mean (SE)b | −0.72 (0.060) | −0.59 (0.058) | −0.54 (0.059) | −0.51 (0.059) |
Difference from fluticasone/formoterol 100/10 μg b.i.d.b | ||||
LS Mean (SE) | −0.13 (0.079) | −0.18 (0.079) | −0.21 (0.081) | |
95% CI | −0.29, 0.03 | −0.33, -0.02 | −0.37, -0.05 | |
p-value* | 0.100 | 0.027† | 0.011** | |
Sleep disturbance scores | n = 112 | n = 116 | n = 115 | n = 108 |
Baselinea, mean (SD) | 0.5 (0.54) | 0.5 (0.45) | 0.4 (0.49) | 0.6 (0.57) |
Change to week 12 | ||||
LS Mean (SE)b | −0.36 (0.033) | −0.34 (0.032) | −0.28 (0.033) | −0.27 (0.033) |
Difference from fluticasone/formoterol 100/10 μg b.i.d.b | ||||
LS Mean (SE) | −0.02 (0.043) | −0.09 (0.044) | −0.10 (0.044) | |
95% CI | −0.11, 0.07 | −0.17, 0.00 | −0.18, -0.01 | |
p-value* | 0.632 | 0.053 | 0.031† |