A1(n = 122) | A2(n = 369) | B1(n = 420) | B2(n = 1254) | C1(n = 269) | C2(n = 811) | D1(n = 268) | D2(n = 811) | ||
---|---|---|---|---|---|---|---|---|---|

Trough FEV_{1} (L) | 1.826[1.780, 1.873] | 1.892[1.865, 1.919] | 1.800[1.777, 1.824] | 1.822[1.808, 1.835] | 1.685 [1.654, 1.715] | 1.756[1.738, 1.774] | 1.673[1.646, 1.699] | 1.774[1.759, 1.790] | |

Differences in trough FEV_{1} (L) | 0.065[0.011, 0.119]* | 0.021[−0.006, 0.048] ^{#}
| 0.071[0.036, 0.107]** | 0.101[0.071, 0.132]** | |||||

Patients with MCID in trough FEV_{1}( ≥ 100 mL)^{†} | 1.770(1.150, 2.724) | 1.401 (1.092, 1.798) | 1.902 (1.421, 2.546) | 2.526(1.863, 3.424) | |||||

TDI | 0.51 [−0.01, 1.03 ] | 2.30[2.00, 2.60 ] | 0.70[0.42, 0.98 ] | 1.44[1.27, 1.60 ] | 0.90[0.47, 1.23 ] | 1.95 [1.72, 2.18] | 0.90[0.51, 1.22 ] | 2.12[1.91, 2.33 ] | |

Differences in TDI | 1.79 [1.19, 2.39]** | 0.74 [0.41, 1.06] ^{#} | 1.10 [0.652, 1.55]** | 1.26 [0.848, 1.67]** | |||||

Patients with MCID in TDI ( ≥ 1 point)^{†} | 4.58[2.86, 7.34] | 2.57[2.00, 3.29] | 2.609[1.94, 3.50] | 2.853[2.13, 3.82] |

All data are LSM Data with [95% CI], unless otherwise stated

†Odds ratios are displayed with [95% CI]

Linear mixed model. All primary efficacy analysis are superiority analysis except B1-B2 which are non-inferiority analysis.

Group B: non-inferiority testing (Δ: −40mL for trough FEV

_{1}and −0.6 points for TDI)* p < 0.05; ** p < 0.0001;

^{#}p < 0.0001 (non-inferiority)A1 (any SABA and/or SAMA), A2 (GLY), B1 (any LAMA or LABA and mMRC = 1), B2 (GLY and mMRC = 1)

C1 (any LABA and ICS), C2 (IND/GLY), D1 (any LAMA or LABA and mMRC > 1), D2 (IND/GLY and mMRC > 1)

CI: confidence intervals; LSM: least square means; OR: odds ratio; MCID, minimal clinically important difference