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Table 3 LS mean (95% CI) change from baseline in trough FEV1 at Day 169

From: Impact of prior and concurrent medication on exacerbation risk with long-acting bronchodilators in chronic obstructive pulmonary disease: a post hoc analysis

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
  1. Δ, pairwise treatment comparison; low rescue use: < 3.6 puffs/day; high rescue use: ≥ 3.6 puffs/day
  2. BL baseline, CI confidence interval, ICS inhaled corticosteroid, ITT intent-to-treat, LS least squares, PBO placebo, UMEC umeclidinium, VI vilanterol