Table 2.
Summary of change from baseline in lung function end points and patient-reported outcomes for the intent-to-treat population
| Number | UMEC/VI | Number | TIO/OLO | Difference/ORb UMEC/VI vs TIO/OLO | |
|---|---|---|---|---|---|
| Trough FEV1 (mL) | |||||
| Baseline, meana | 234 | 1539 (453) | 229 | 1587 (445) | – |
| Change from baseline to | |||||
| Week 4 | 231 | 189 (13) | 224 | 141 (13) | 48 (25–71)c |
| Week 8 | 225 | 180 (13) | 224 | 128 (13) | 52 (28–77)c |
| Trough FEV1 responders | |||||
| Week 4 | 234 | 162 (69%) | 227 | 116 (51%) | OR: 2.09 (1.39–3.14)c |
| Week 8 | 234 | 154 (66%) | 229 | 109 (48%) | OR: 2.05 (1.34–3.14)c |
| FVC (mL) | |||||
| Baseline, meana | 234 | 2808 (822) | 229 | 2863 (799) | – |
| Change from baseline to | |||||
| Week 4 | 231 | 214 (18) | 224 | 174 (18) | 40 (5–75)d |
| Week 8 | 225 | 202 (18) | 224 | 135 (18) | 67 (34–100)c |
| IC (mL) | |||||
| Baseline, meana | 227 | 2355 (620) | 224 | 2379 (603) | – |
| Change from baseline to | |||||
| Week 4 | 223 | 164 (17) | 215 | 112 (18) | 52 (16–88)e |
| Week 8 | 212 | 169 (17) | 212 | 122 (17) | 47 (14–81)e |
| Baseline rescue medication use (puffs/day), meana | 222 | 2.65 (3.27) | 217 | 2.26 (2.81) | – |
| Change from baseline in rescue medication use (weeks 1–8) (puffs/day) | 222 | − 0.94 (0.08) | 217 | − 0.68 (0.08) | − 0.25 (− 0.37 to − 0.14)c |
| Baseline rescue medication-free days, meana | 222 | 40.08 (44.54) | 217 | 44.76 (44.13) | – |
| Change from baseline in rescue medication-free days (weeks 1–8) | 222 | 8.04 (2.14) | 217 | 6.13 (2.15) | 1.91 (− 0.71 to 4.53) |
| CAT score | |||||
| Baseline, meana | 233 | 18.03 (7.40) | 225 | 17.48 (7.17) | – |
| Change from baseline to | |||||
| Week 4 | 230 | − 1.60 (0.28) | 220 | − 1.01 (0.29) | − 0.59 (− 1.16 to − 0.02)d |
| Week 8 | 221 | − 1.38 (0.28) | 220 | − 1.26 (0.28) | − 0.11 (− 0.68 to 0.45) |
| CAT responders | |||||
| Week 4 | 231 | 107 (46%) | 222 | 86 (39%) | OR: 1.25 (0.85–1.82) |
| Week 8 | 233 | 107 (46%) | 225 | 94 (42%) | OR: 1.05 (0.72–1.55) |
All changes from baseline are presented as the least squares mean (standard error) change from baseline, unless otherwise stated. Negative COPD Assessment Test (CAT) scores indicate clinical improvement. CAT responders were defined as those with a decrease of 2 units or more from baseline [baseline CAT score, umeclidinium/vilanterol (UMEC/VI; 62.5/25 µg) 18.03 (standard deviation 7.40), tiotropium/olodaterol (TIO/OLO; 5/5 µg) 17.48 (standard deviation 7.17)]. Baseline rescue medication use: UMEC/VI (62.5/25 µg) 2.65 (standard deviation 3.27); TIO/OLO (5/5 µg) 2.26 (standard deviation 2.81).
CI confidence interval, COPD chronic obstructive pulmonary disease, FEV 1 forced expiratory volume in 1 s, FVC forced vital capacity, IC inspiratory capacity, OR odds ratio
aThe standard deviation is given in parentheses
bThe 95% confidence interval is given in parentheses
c p < 0.001
d p < 0.05
e p < 0.01