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 | |
Baseline FEV1 (L) | ||||
Mean (SD) | 2.416 (0.5790) | 2.425 (0.6625) | 2.459 (0.6231) | 2.352 (0.6114) |
Change in FEV1 from pre-dose at baseline to pre-dose at week 12 | ||||
LS Mean (SE) | 0.195 (0.038) | 0.092 (0.037) | 0.094 (0.038) | 0.047 (0.037) |
Difference from fluticasone/formoterol 100/10 μg b.i.d.: contribution from fluticasone component | ||||
LS Mean (SE) | 0.103 (0.050) | 0.101 (0.050) | 0.147 (0.051) | |
95% CI | 0.005, 0.201 | 0.002, 0.199 | 0.048, 0.247 | |
p-value | 0.040 | 0.045 | 0.004 | |
Change in FEV1 from pre-dose at baseline to 2 hours post-dose at week 12 | ||||
LS Mean (SE) | 0.392 (0.035) | 0.191 (0.034) | 0.330 (0.035) | 0.124 (0.035) |
Difference from fluticasone/formoterol 100/10 μg b.i.d.: contribution from formoterol component | ||||
LS Mean (SE) | 0.200 (0.047) | 0.062 (0.047) | 0.267 (0.047) | |
95% CI | 0.109, 0.292 | −0.030, 0.153 | 0.175, 0.360 | |
p-value | < 0.001 | 0.187 | < 0.001 | |
Discontinuation due to lack of efficacy | ||||
Number, % | 7 (6.1) | 9 (7.7) | 13 (11.2) | 18 (16.2) |
Time to discontinuation, weeksa | ||||
Mean | 6.9 | 4.7 | 4.6 | 5.5 |
p-value b | 0.015 |