Patient group/subgroup | UMEC/VI vs PBO | UMEC vs PBO | VI vs PBO | UMEC/VI vs UMEC | UMEC/VI vs VI | |||||
---|---|---|---|---|---|---|---|---|---|---|
Δ mL | Δ % | Δ mL | Δ % | Δ mL | Δ % | Δ mL | Δ % | Δ mL | Δ % | |
ITT population (N = 3021) | 200 | 17.8 | 136 | 11.8 | 96 | 8.5 | 64 | 5.4 | 104 | 8.6 |
(173, 228) | (15.4, 20.3) | (109, 164) | (9.5, 14.1) | (69, 124) | (6.2, 10.7) | (40, 88) | (3.5, 7.4) | (80, 128) | (6.7, 10.6) | |
p < 0.001 | p < 0.001 | p < 0.001 | p < 0.001 | p < 0.001 | p < 0.001 | p < 0.001 | p < 0.001 | p < 0.001 | p < 0.001 | |
Patient subgroups | ||||||||||
 Maintenance-naïve | 209 | 17.2 | 149 | 12.3 | 137 | 11.6 | 60 | 4.3 | 72 | 5.1 |
 (n = 984) | (159, 260) | (13.1, 21.5) | (97, 202) | (8.3, 16.6) | (85, 189) | (7.6, 15.7) | (14, 106) | (1.0, 7.7) | (27, 117) | (1.8, 8.4) |
p < 0.001 | p < 0.001 | p < 0.001 | p < 0.001 | p < 0.001 | p < 0.001 | p = 0.011 | p = 0.010 | p = 0.002 | p = 0.002 | |
 On maintenance | 195 | 18.1 | 131 | 11.6 | 75 | 6.9 | 63 | 5.8 | 120 | 10.5 |
 (n = 2037) | (162, 227) | (15.2, 21.2) | (99, 163) | (8.8, 14.4) | (42, 107) | (4.2, 9.6) | (35, 91) | (3.5, 8.2) | (91, 148) | (8.1, 13.0) |
p < 0.001 | p < 0.001 | p < 0.001 | p < 0.001 | p < 0.001 | p < 0.001 | p < 0.001 | p < 0.001 | p < 0.001 | p < 0.001 | |
 ICS-free (n = 1543) | 204 | 17.7 | 150 | 12.9 | 127 | 11.1 | 54 | 4.2 | 76 | 5.9 |
(164, 243) | (14.4, 21.1) | (110, 190) | (9.7, 16.2) | (88, 167) | (8.0, 14.4) | (19, 88) | (1.6, 6.8) | (41, 111) | (3.3, 8.6) | |
p < 0.001 | p < 0.001 | p < 0.001 | p < 0.001 | p < 0.001 | p < 0.001 | p = 0.003 | p = 0.001 | p < 0.001 | p < 0.001 | |
 ICS-treated (n = 1478) | 198 | 18.1 | 124 | 10.8 | 64 | 5.8 | 74 | 6.6 | 134 | 11.7 |
(160, 236) | (14.6, 21.7) | (86, 162) | (7.5, 14.1) | (26, 102) | (2.6, 9.0) | (41, 107) | (3.9, 9.5) | (101, 168) | (8.8, 14.7) | |
p < 0.001 | p < 0.001 | p < 0.001 | p < 0.001 | p = 0.001 | p < 0.001 | p < 0.001 | p < 0.001 | p < 0.001 | p < 0.001 | |
 Low rescue use | 206 | 17.2 | 158 | 13.0 | 101 | 8.3 | 48 | 3.7 | 105 | 8.2 |
 (n = 1488) | (169, 243) | (14.1, 20.4) | (121, 195) | (10.0, 16.1) | (64, 139) | (5.4, 11.3) | (16, 80) | (1.3, 6.1) | (72, 137) | (5.7, 10.7) |
p < 0.001 | p < 0.001 | p < 0.001 | p < 0.001 | p < 0.001 | p < 0.001 | p = 0.003 | p = 0.002 | p < 0.001 | p < 0.001 | |
 High rescue use | 194 | 18.4 | 113 | 10.3 | 88 | 8.3 | 81 | 7.3 | 106 | 9.4 |
 (n = 1490) | (153, 235) | (14.7, 22.3) | (72, 154) | (6.8, 13.9) | (47, 129) | (4.9, 11.8) | (44, 118) | (4.3, 10.5) | (69, 142) | (6.3, 12.5) |
p < 0.001 | p < 0.001 | p < 0.001 | p < 0.001 | p < 0.001 | p < 0.001 | p < 0.001 | p < 0.001 | p < 0.001 | p < 0.001 |