Table 3.
Secondary outcomes (ITT population)
| Placebo | VI 6.25 μg | VI 12.5 μg | VI 25 μg | |
|---|---|---|---|---|
| N = 115 | N = 114 | N = 113 | N = 114 | |
| Primary endpoint | ||||
| Mean change from baseline in daily evening PEF Weeks 1–4 (L/min) | ||||
| n | 113 | 113 | 112 | 110 |
| LS mean | 215.9 | 221.4 | 222.4 | 220.3 |
| LS mean change (SE) | 4.5 (2.53) | 10.0 (2.53) | 11.0 (2.54) | 8.9 (2.56) |
| Diff. vs placebo | 5.5 | 6.4 | 4.4 | |
| 95 % CI | −1.6, 12.5 | −0.6, 13.5 | −2.7, 11.4 | |
| p-value | 0.127 | 0.073 | 0.227 | |
| Secondary endpoints | ||||
| Change from baseline in trough FEV1 (L) at Week 4 (LOCF) | ||||
| n | 85 | 83 | 86 | 86 |
| LS mean | 1.616 | 1.559 | 1.632 | 1.586 |
| LS mean change (SE) | 0.223 (0.029) | 0.166 (0.029) | 0.240 (0.029) | 0.193 (0.029) |
| Diff. vs placebo | −0.057 | 0.017 | −0.030 | |
| 95 % CI | −0.138, 0.024 | −0.063, 0.096 | −0.110, 0.051 | |
| Change from baseline in percentage of rescue-free 24-h periods, Weeks 1–4 | ||||
| n | 113 | 113 | 112 | 110 |
| LS mean change (SE) | 14.4 (2.97) | 12.2 (2.97) | 15.8 (2.98) | 23.1 (3.01) |
| Diff. vs placebo | −2.3 | 1.3 | 8.7 | |
| 95 % CI | −10.5, 6.0 | −6.9, 9.6 | 0.4, 17.0 | |
| Change from baseline in percentage of symptom-free 24-h periods, Weeks 1–4 | ||||
| n | 113 | 113 | 112 | 110 |
| LS mean change (SE) | 9.9 (2.65) | 10.1 (2.65) | 18.3 (2.66) | 19.7 (2.69) |
| Diff. vs placebo | 0.2 | 8.3 | 9.8 | |
| 95 % CI | −7.2, 7.5 | 1.0, 15.7 | 2.3, 17.2 | |
| Change from baseline in morning PEF (L/min), Weeks 1–4 | ||||
| n | 114 | 113 | 112 | 110 |
| LS mean | 206.3 | 211.8 | 213.8 | 213.5 |
| LS mean change (SE) | 6.4 (2.42) | 12.0 (2.43) | 13.9 (2.44) | 13.7 (2.46) |
| Diff. vs placebo | 5.5 | 7.5 | 7.2 | |
| 95 % CI | −1.2, 12.3 | 0.7, 14.2 | 0.4, 14.0 | |
| Change from Baseline in morning PEF (L/min), endpoint – Week 4 (LOCF) | ||||
| n | 114 | 113 | 112 | 110 |
| LS mean | 207.2 | 213.1 | 216.9 | 214.2 |
| LS mean change (SE) | 7.4 (3.45) | 13.3 (3.47) | 17.0 (3.48) | 14.4 (3.51) |
| Diff. vs placebo | 5.9 | 9.7 | 7.0 | |
| 95 % CI | −3.7, 15.6 | 0.0, 19.3 | −2.7, 16.7 | |
| Change from Baseline in evening PEF (L/min), endpoint - Week 4 (LOCF) | ||||
| n | 113 | 113 | 112 | 110 |
| LS mean | 217.3 | 220.8 | 225.1 | 222.5 |
| LS mean change (SE) | 5.9 (3.44) | 9.4 (3.44) | 13.7 (3.45) | 11.1 (3.48) |
| Diff. vs placebo | 3.5 | 7.8 | 5.2 | |
| 95 % CI | −6.1, 13.1 | −1.8, 17.4 | −4.4, 14.9 | |
| Other endpoints | ||||
| Change from baseline in cACT score by baseline category at Week 4a | ||||
| Baseline cACT Score <20 | ||||
| n | 48 | 57 | 59 | 56 |
| LS mean | 19.5 | 19.8 | 20.2 | 20.9 |
| LS mean change (SE) | 3.5 (0.54) | 3.8 (0.49) | 4.2 (0.48) | 4.9 (0.50) |
| Diff. vs placebo | 0.3 | 0.7 | 1.4 | |
| 95 % CI | −1.2, 1.7 | −0.7, 2.1 | −0.1, 2.9 | |
| Baseline cACT Score ≥20 | ||||
| n | 50 | 39 | 47 | 36 |
| LS mean | 22.9 | 21.5 | 21.9 | 22.5 |
| LS mean change (SE) | 0.8 (0.48) | −0.5 (0.53) | −0.2 (0.48) | 0.5 (0.55) |
| Diff. vs placebo | −1.3 | −1.0 | −0.4 | |
| 95 % CI | −2.8, 0.1 | −2.4, 0.4 | −1.8, 1.1 | |
cACT childhood asthma control test, CI confidence interval, FEV 1 forced expiratory volume in one second, ITT intention-to-treat, LS least squares, PEF peak expiratory flow, SE standard error, VI vilanterol
acACT data are post-hoc analyses