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Table 3 Secondary lung function endpoints (ITT population)

From: Once-daily single-inhaler versus twice-daily multiple-inhaler triple therapy in patients with COPD: lung function and health status results from two replicate randomized controlled trials

EndpointStudy 207608Study 207609Pooled 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
n354355360356714711
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 baseline54 (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
n358359355341713700
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 baseline8 (−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
n355353353354708707
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 baseline46 (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
n344340346343690683
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 baseline40 (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
n341337343342684679
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 baseline26 (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)
  1. n number of patients with analyzable data at the current time point
  2. BUD budesonide; CI confidence interval; FEV1forced expiratory volume in 1 s; FF fluticasone furoate; FOR formoterol; ITT intent-to-treat; LS least squares; TIO tiotropium; UMEC umeclidinium; VI vilanterol; wm weighted mean