Table 3 Secondary lung function endpoints (ITT population)
Endpoint | Study 207608 | Study 207609 | Pooled analysis | |||
|---|---|---|---|---|---|---|
FF/UMEC/VI N = 363 | BUD/FOR+TIO N = 365 | FF/UMEC/VI N = 366 | BUD/FOR+TIO N = 366 | FF/UMEC/VI N = 729 | BUD/FOR+TIO N = 731 | |
0–24-h wmFEV1on Day 1,mL | ||||||
n | 354 | 355 | 360 | 356 | 714 | 711 |
LS mean (95% CI) | 1217 (1202, 1233) | 1226 (1211, 1242) | 1195 (1182, 1209) | 1191 (1178, 1205) | 1206 (1196, 1216) | 1209 (1199, 1219) |
LS mean (95% CI) change from baseline | 54 (39, 69) | 63 (48, 78) | 45 (32, 59) | 41 (28, 55) | 49 (39, 59) | 52 (42, 62) |
Treatment difference (95% CI) | −9 (−30, 13) | 4 (−16, 23) | −3 (− 17, 11) | |||
Trough FEV1on Day 2, mL | ||||||
n | 358 | 359 | 355 | 341 | 713 | 700 |
LS mean (95% CI) | 1171 (1152,1190) | 1181 (1161, 1200) | 1164 (1147, 1180) | 1138 (1121, 1155) | 1167 (1154, 1180) | 1160 (1147, 1173) |
LS mean (95% CI) change from baseline | 8 (−11, 27) | 18 (−2, 37) | 15 (−2, 32) | −10 (−28, 7) | 11 (− 2, 24) | 4 (−9, 17) |
Treatment difference (95% CI) | − 10 (−37, 18) | 26 (2, 49) | 7 (− 11, 25) | |||
Trough FEV1on Day 28, mL | ||||||
n | 355 | 353 | 353 | 354 | 708 | 707 |
LS mean (95% CI) | 1210 (1192, 1227) | 1148 (1131, 1165) | 1193 (1174, 1211) | 1130 (1111, 1149) | 1201 (1188, 1214) | 1139 (1127, 1152) |
LS mean (95% CI) change from baseline | 46 (29, 64) | −15 (−32, 2) | 44 (25, 63) | −19 (− 37, 0) | 45 (32, 58) | −16 (−29, −4) |
Treatment difference (95% CI) | 61 (37, 86) | 63 (36, 89) | 62 (44, 80) | |||
Trough FEV1on Day 84, mL | ||||||
n | 344 | 340 | 346 | 343 | 690 | 683 |
LS mean (95% CI) | 1203 (1185, 1221) | 1145 (1127, 1164) | 1173 (1153, 1193) | 1119 (1099, 1139) | 1188 (1174, 1201) | 1132 (1118, 1146) |
LS mean (95% CI) change from baseline | 40 (22, 58) | −18 (−36, 1) | 24 (5, 44) | −30 (−50, − 10) | 32 (18, 46) | −24 (− 37, − 10) |
Treatment difference (95% CI) | 58 (32, 84) | 54 (26, 83) | 56 (37, 75) | |||
Trough FEV1on Day 85, mL | ||||||
n | 341 | 337 | 343 | 342 | 684 | 679 |
LS mean (95% CI) | 1189 (1169, 1208) | 1151 (1131,1170) | 1178 (1156, 1200) | 1127 (1105, 1148) | 1183 (1169, 1198) | 1139 (1124, 1153) |
LS mean (95% CI) change from baseline | 26 (6, 45) | −12 (−32, 7) | 29 (8, 51) | −22, (−44, 0) | 28 (13, 42) | −17 (− 32, − 2) |
Treatment difference (95% CI) | 38 (10, 66) | 51 (21, 82) | 45 (24, 65) | |||