N | UMEC/VI | N | TIO/OLO | Difference/OR (95% CI) UMEC/VI vs TIO/OLO | |
---|---|---|---|---|---|
Trough FEV1, mL | |||||
Week 4 | 231 | 189 (13) | 224 | 141 (13) | +48 (25, 71)* |
Week 8 | 225 | 180 (13) | 224 | 128 (13) | +52 (28, 77)* |
Trough FEV1 responders,† n (%) | |||||
Week 4 | 234 | 162 (69) | 227 | 116 (51) | OR: 2.09 (1.39, 3.14)* |
Week 8 | 234 | 154 (66) | 229 | 109 (48) | OR: 2.05 (1.34, 3.14)* |
IC, mL | |||||
Week 4 | 223 | 164 (17) | 215 | 112 (18) | +52 (16, 88)** |
Week 8 | 212 | 169 (17) | 212 | 122 (17) | +47 (14, 81)** |
Rescue medication use
(Weeks 1–8), puffs/day | 222 | −0.94 (0.08) | 217 | −0.68 (0.08) | −0.25 (-0.37,–0.14)* |
All data are presented as LS mean (SE) change from baseline, unless otherwise stated;
*p<0.001; **p<0.01; † Defined as a change from baseline in trough FEV1 of ≥100 mL
CI, confidence interval; FEV1, forced expiratory volume in 1 s; IC, inspiratory capacity; ITT, intent-to-treat; LS, least squares; OR, odds ratio; SE, standard error; TIO/OLO, tiotropium/olodaterol 5/5 mcg; UMEC/VI, umeclidinium/vilanterol 62.5/25 mcg